DESIGN END USER RISK ANALYSIS

(d-EURA)
EURA Project Leader: Mohamed Riyas Rahamathulla (R&D)
PRODUCT DESCRIPTION: Hypodermic Needle EURA Project Team: Leilei Zhang (Unit R&D), Vishal Joshi (Unit QA), Regina Haywood (Medical Affairs),
Std/Conv Needles, SoloMed, Eclipse, Microlance Needle, Discardit II,
PRODUCTS AFFECTED: SafetyGlide Needle, Precision Glide Needle, Soloshot Mini, H1000 Needle Murtaza Rana (Regulatory), Carl Chrisbacher (Operations)

DOCUMENT NO.: RM370 REV. NO.: 05

EXISTING CONDITIONS ACTION RESULTS

RISK BENEFIT ANALYSIS

RISK EVALUATION

RISK EVALUATION
OCCURRENCE

OCCURRENCE
POTENTIAL

SEVERITY

SEVERITY
POTENTIAL FAILURE POTENTIAL CAUSES RECOMMENDED
ITEM ITEM FUNCTIONS EFFECTS OF ASSUMPTIONS
MODES OF FAILURE RISK CONTROLS ACTIONS ACTIONS TAKEN
FAILURE

Hub Holds Cannula Cannula Falls off • Hub lumen ID • Needle remains • Material
too large in vial - user properties as per
• Incorrect annoyance BD requirement 1 1 Acceptable N/A
material selection • Product
• Cannula falls off - Specification Severity ranges 1-3
Patient get • BD Hub Drawing
inaccurate dose 1 3 Acceptable N/A

• Potential for Severity ranges 1-3

leakage resulting
in exposure to
toxic/non-toxic 1 3 Acceptable N/A
meds

• Potential for
leakage resulting
in exposure to 1 3 Acceptable N/A
blood/body fluids

• Potential for
leakage resulting
exposure
bloodborne 1 4 Unacceptable N/A RBA #1
pathogens with
seroconversion

• Restart the Severity ranges 1-3

procedure 1 3 Acceptable N/A
 DESIGN END USER RISK ANALYSIS
(d-EURA)
DOCUMENT NO.: RM370 REV. NO.: 05

EXISTING CONDITIONS ACTION RESULTS

RISK BENEFIT ANALYSIS

RISK EVALUATION

RISK EVALUATION
OCCURRENCE

OCCURRENCE
POTENTIAL

SEVERITY

SEVERITY
POTENTIAL FAILURE POTENTIAL CAUSES RECOMMENDED
ITEM ITEM FUNCTIONS EFFECTS OF ASSUMPTIONS
MODES OF FAILURE RISK CONTROLS ACTIONS ACTIONS TAKEN
FAILURE

Cannula not held • Hub lumen ID • Cannot use the • Material

straight (Cannula too large product - properties as per
Angularity) • Incorrect Customer BD requirement
1 1 Acceptable N/A
material selection annoyance • Product
Specification
• BD Hub Drawing
• Clean needle
stick injury -
needle 1 2 Acceptable N/A
pierces through
needle shield
Needle injection • Incorrect Hub • Cannot use the • Material
length too short/too Design product - properties as per
long Incorrect material Customer BD requirement
selection annoyance • Product 1 1 Acceptable N/A
Specification
• BD Hub Drawing
• Delay in Severity ranges 1-3
treatment 1 3 Acceptable N/A

Clogged Cannula • Incorrect Hub • Unable to use • Material

lumen design product leading to properties as per
• Incorrect customer BD requirement 1 1 Acceptable N/A
material selection annoyance • Product
Specification
• BD Hub Drawing
• Restart Severity ranges 1-3
Procedure 1 3 Acceptable N/A

Leaks at cannula • Incorrect Hub • Needle remains • Material

Design in vial - user properties as per
• Incorrect Material annoyance BD requirement
selected • Product 1 1 Acceptable N/A
Specification
• BD Hub Drawing
 DESIGN END USER RISK ANALYSIS
(d-EURA)
DOCUMENT NO.: RM370 REV. NO.: 05

EXISTING CONDITIONS ACTION RESULTS

RISK BENEFIT ANALYSIS

RISK EVALUATION

RISK EVALUATION
OCCURRENCE

OCCURRENCE
POTENTIAL

SEVERITY

SEVERITY
POTENTIAL FAILURE POTENTIAL CAUSES RECOMMENDED
ITEM ITEM FUNCTIONS EFFECTS OF ASSUMPTIONS
MODES OF FAILURE RISK CONTROLS ACTIONS ACTIONS TAKEN
FAILURE

• Potential for Severity ranges 1-3

leakage resulting
in exposure to
toxic/non-toxic 1 3 Acceptable N/A
meds

• Potential for
leakage resulting
in exposure to
1 3 Acceptable N/A
blood/body fluids

• Potential for
leakage resulting
exposure
bloodborne
1 4 Unacceptable N/A RBA #1
pathogens with
seroconversion

• Restart the Severity ranges 1-3

procedure 1 3 Acceptable N/A

Holds Needle Shield pull off force • Incorrect Hub • Unable to pull • Material
shield too high Design the shield - properties as per
• Incorrect Material Customer BD requirement 1 1 Acceptable N/A
selection annoyance • Product
Specification
• BD Hub Drawing
• Rebound Needle
stick injury (clean)
1 2 Acceptable N/A
 DESIGN END USER RISK ANALYSIS
(d-EURA)
DOCUMENT NO.: RM370 REV. NO.: 05

EXISTING CONDITIONS ACTION RESULTS

RISK BENEFIT ANALYSIS

RISK EVALUATION

RISK EVALUATION
OCCURRENCE

OCCURRENCE
POTENTIAL

SEVERITY

SEVERITY
POTENTIAL FAILURE POTENTIAL CAUSES RECOMMENDED
ITEM ITEM FUNCTIONS EFFECTS OF ASSUMPTIONS
MODES OF FAILURE RISK CONTROLS ACTIONS ACTIONS TAKEN
FAILURE

Shield pull off force • Incorrect Hub • Shield slips off • Material
too low Design rubbing the properties as per
• Incorrect Material cannula resulting BD requirement
selection cannula tip • Product
damage. Specification
1 1 Acceptable N/A
Customer • BD Hub Drawing
annoyance,
discards product

• Shield falls off

resulting in clean
needle stick injury 1 2 Acceptable N/A

Connects with luer Loose connection • Incorrect Hub • Needle remains • Material
mating device Design in vial - user properties as per
• Incorrect Material annoyance BD requirement 1 1 Acceptable N/A
selection • Product
• Potential for Specification Severity ranges 1-3
leakage resulting • BD Hub Drawing
in patient to get
inaccurate dose 1 3 Acceptable N/A

• Potential for Severity ranges 1-3

leakage resulting
exposure to
toxic/non-toxic 1 3 Acceptable N/A
meds

• Potential for
leakage resulting
exposure to
blood/body fluids 1 3 Acceptable N/A
 DESIGN END USER RISK ANALYSIS
(d-EURA)
DOCUMENT NO.: RM370 REV. NO.: 05

EXISTING CONDITIONS ACTION RESULTS

RISK BENEFIT ANALYSIS

RISK EVALUATION

RISK EVALUATION
OCCURRENCE

OCCURRENCE
POTENTIAL

SEVERITY

SEVERITY
POTENTIAL FAILURE POTENTIAL CAUSES RECOMMENDED
ITEM ITEM FUNCTIONS EFFECTS OF ASSUMPTIONS
MODES OF FAILURE RISK CONTROLS ACTIONS ACTIONS TAKEN
FAILURE

• Potential for
leakage resulting
exposure
bloodborne
pathogens with 1 4 Unacceptable N/A RBA #1
seroconversion

• Restart the Severity ranges 1-3

procedure 1 3 Acceptable N/A

Tight connection • Incorrect Hub • Cannot use • Material

leading to hub Design product - properties as per
cracking/breaking • Incorrect Material Customer BD requirement
1 1 Acceptable N/A
selection annoyance • Product
Specification
• BD Hub Drawing
• Potential for Severity ranges 1-3
leakage resulting
in exposure to
toxic/non-toxic 1 3 Acceptable N/A
meds

• Potential for
leakage resulting
in exposure to
blood/body fluids 1 3 Acceptable N/A

• Potential for
leakage resulting
exposure
bloodborne
pathogens with 1 4 Unacceptable N/A RBA #1
seroconversion
 DESIGN END USER RISK ANALYSIS
(d-EURA)
DOCUMENT NO.: RM370 REV. NO.: 05

EXISTING CONDITIONS ACTION RESULTS

RISK BENEFIT ANALYSIS

RISK EVALUATION

RISK EVALUATION
OCCURRENCE

OCCURRENCE
POTENTIAL

SEVERITY

SEVERITY
POTENTIAL FAILURE POTENTIAL CAUSES RECOMMENDED
ITEM ITEM FUNCTIONS EFFECTS OF ASSUMPTIONS
MODES OF FAILURE RISK CONTROLS ACTIONS ACTIONS TAKEN
FAILURE

• Restart the Severity ranges 1-3

procedure 1 3 Acceptable N/A

Helps to Identify Wrong gauge • Incorrect • Cannot correctly • Material

Needle gauge selected for the material selection identify color code- properties as per
treatment • Incorrect Clinician BD requirement
Colorant selection annoyance • Product
Specification
1 1 Acceptable N/A
• Colorant
selection per BD
requirement

Cannula Penetrate septum Difficult to insert in • Incorrect bevel • High penetration • Material
(Vial / IV Bags / IV septum geometry force for IV bag properties as per
Ports Etc.) or Skin. • Incorrect etc.- Customer BD requirement
material selection annoyance • Product
Specification 1 1 Acceptable N/A
• BD Cannula
Drawing

Coring and • Incorrect bevel • Clogged cannula • Material

particulate geometry - annoyance properties as per
1 2 Acceptable N/A
generation • Incorrect BD requirement
material selection • Product
• Foreign matter Specification
injected into • BD Cannula
patient's skin Drawing 1 3 Acceptable N/A
(granuloma)
Severity ranges 1-3
Foreign matter in
medication 1 3 Acceptable N/A
 DESIGN END USER RISK ANALYSIS
(d-EURA)
DOCUMENT NO.: RM370 REV. NO.: 05

EXISTING CONDITIONS ACTION RESULTS

RISK BENEFIT ANALYSIS

RISK EVALUATION

RISK EVALUATION
OCCURRENCE

OCCURRENCE
POTENTIAL

SEVERITY

SEVERITY
POTENTIAL FAILURE POTENTIAL CAUSES RECOMMENDED
ITEM ITEM FUNCTIONS EFFECTS OF ASSUMPTIONS
MODES OF FAILURE RISK CONTROLS ACTIONS ACTIONS TAKEN
FAILURE

Fails to provide • Incorrect bevel • Painful injection • Material

smooth insertion geometry properties as per
• Incorrect BD requirement
material selection • Product
Specification 1 2 Acceptable N/A
• BD Cannula
Drawing

Allow fluid flow High/Low forces • Cannula ID too • Difficulty in • BD Cannula

during aspiration or small aspiration- Drawing
expulsion of fluid • Incorrect Customer • Material
material selection annoyance properties as per 1 1 Acceptable N/A
BD requirement

Provide sufficient Needle injection • Incorrect • Discards product • Material

injection length length too short/too Cannula length leading to properties as per
long • Incorrect customer BD requirement
1 1 Acceptable N/A
material selection annoyance • Product
Specification
• BD Cannula
Delay in treatment Drawing Severity ranges 1-3
1 3 Acceptable N/A

Shield Protect Shield interface with • Incorrect Shield • Shield falls off • Product
needle/end user hub is too loose rib design immediately after Specification
• Incorrect removing from • BD Shield
material selection package - Drawing 1 1 Acceptable N/A
• Excessive lube Customer • Material
annoyance properties as per
BD requirement
• Clean needle
stick injury due to
shield 1 2 Acceptable N/A
inadvertently
coming off
 DESIGN END USER RISK ANALYSIS
(d-EURA)
DOCUMENT NO.: RM370 REV. NO.: 05

EXISTING CONDITIONS ACTION RESULTS

RISK BENEFIT ANALYSIS

RISK EVALUATION

RISK EVALUATION
OCCURRENCE

OCCURRENCE
POTENTIAL

SEVERITY

SEVERITY
POTENTIAL FAILURE POTENTIAL CAUSES RECOMMENDED
ITEM ITEM FUNCTIONS EFFECTS OF ASSUMPTIONS
MODES OF FAILURE RISK CONTROLS ACTIONS ACTIONS TAKEN
FAILURE

• Potential for
contamination -
1 1 Acceptable N/A
user discards

Shield interface with • Incorrect Shield • High shield • Product

hub is too tight rib design removal force - Specification
• Incorrect Customer • BD Shield 1 1 Acceptable N/A
material selection annoyance Drawing

• Rebound needle
stick
injury (clean) 1 2 Acceptable N/A

Cannula pierces • Incorrect • Cannot use as • Material

thru shield material selection the product is properties as per
• Shield wall too damaged - BD requirement
thin Customer • BD Shield 1 1 Acceptable N/A
annoyance Drawing

• Clean Needle
stick Injury
1 2 Acceptable N/A

Epoxy Bonds cannula to Cannula pull force • Incorrect epoxy • Needle remains • Material
hub too low/falls off material selection in vial - user properties as per
• Insufficient annoyance BD requirement
quantity of epoxy 1 1 Acceptable N/A
selected

Needle remains in
patient - clinician
removes 1 1 Acceptable N/A
 DESIGN END USER RISK ANALYSIS
(d-EURA)
DOCUMENT NO.: RM370 REV. NO.: 05

EXISTING CONDITIONS ACTION RESULTS

RISK BENEFIT ANALYSIS

RISK EVALUATION

RISK EVALUATION
OCCURRENCE

OCCURRENCE
POTENTIAL

SEVERITY

SEVERITY
POTENTIAL FAILURE POTENTIAL CAUSES RECOMMENDED
ITEM ITEM FUNCTIONS EFFECTS OF ASSUMPTIONS
MODES OF FAILURE RISK CONTROLS ACTIONS ACTIONS TAKEN
FAILURE

Clogged Cannula • Incorrect epoxy • Customer • Material

material selection annoyance - cant properties as per
• Epoxy quantity use needle BD requirement
too high selected 1 1 Acceptable N/A

Leakage at epoxy • Incorrect epoxy • Customer • Material

bonding area material selection annoyance due to properties as per
• Insufficient leakage BD requirement 1 1 Acceptable N/A
quantity of epoxy
selected
• Potential for Severity ranges 1-3
leakage resulting
in inaccurate 1 3 Acceptable N/A
dose

• Potential for Severity ranges 1-3

leakage resulting
in exposure to
toxic/non-toxic 1 3 Acceptable N/A
meds

• Potential for
leakage resulting
in exposure to
1 3 Acceptable N/A
blood/body fluids

• Potential for
leakage resulting
exposure
bloodborne
1 4 Unacceptable N/A RBA #1
pathogens with
seroconversion

• Restart the Severity ranges 1-3

procedure 1 3 Acceptable N/A
 DESIGN END USER RISK ANALYSIS
(d-EURA)
DOCUMENT NO.: RM370 REV. NO.: 05

EXISTING CONDITIONS ACTION RESULTS

RISK BENEFIT ANALYSIS

RISK EVALUATION

RISK EVALUATION
OCCURRENCE

OCCURRENCE
POTENTIAL

SEVERITY

SEVERITY
POTENTIAL FAILURE POTENTIAL CAUSES RECOMMENDED
ITEM ITEM FUNCTIONS EFFECTS OF ASSUMPTIONS
MODES OF FAILURE RISK CONTROLS ACTIONS ACTIONS TAKEN
FAILURE

Lubrication Minimize Penetration force • Incorrect • Difficulty • Material

penetration force too high Cannula lube penetrating properties as per
material septum on IV bags BD requirement
• Insufficient etc. -Customer 1 1 Acceptable N/A
quantity of epoxy annoyance
selected

Painful injection
1 2 Acceptable N/A

Source for Ranking Criteria: MS-QS-034 Attachment C Rev 04

Ranking Criteria

End User Failure Mode Effect

Occurrence Ranking Criteria Quantitative Risk Evaluation Chart Qualitative Risk Evaluation Chart
Quantitative
Occurrence Ranking Severity Severity
Criteria
Frequent > 1000 IPM 5 Occurrence 1 2 3 4 5 Occurrence 1 2 3 4 5
1 Remote
Probable ≤ 1000 IPM 4 Acceptable Acceptable Acceptable Unacceptable Unacceptable Acceptable Acceptable Acceptable Unacceptable Unacceptable
2 Occasional
Occasional ≤ 100 IPM 3 Acceptable Acceptable Acceptable Unacceptable Unacceptable Acceptable Acceptable Unacceptable Unacceptable Unacceptable
3 Frequent
Remote ≤ 10.0 IPM 2 Acceptable Acceptable Unacceptable Unacceptable Unacceptable Acceptable Unacceptable Unacceptable Unacceptable Unacceptable
Improbable ≤ 1.0 IPM 1 4 Acceptable Unacceptable Unacceptable Unacceptable Unacceptable
5 Acceptable Unacceptable Unacceptable Unacceptable Unacceptable
*IPM: Incidents per million units

Acceptable: Broadly acceptable – risk should be reduced as far as possible Remote: Rarely if ever observed

Unacceptable-yellow: Risk should be reduced as far as possible. If no additional risk reduction measures are Occasional: Observed but not often.
taken, then documented justification and risk/benefit analysis is required.

Unacceptable - red: The risk without further risk/benefit analysis is intolerable and must be reduced or a Frequent: Often observed.
risk/benefit analysis completed and approved.

End User Failure Mode Effect Severity Ranking Criteria

Ranking Category Definition

1 Negligible No adverse health consequences; may result in annoyance to user or to patient. Could include cosmetic defect and/or need to replace defective
product prior to initial use.
2 Limited Injury, without a significant discomfort or any degree of disability. Symptoms are transient easily tolerated with no interference with subject’s daily
activities. Illness or injuries are transient, self limited and require no medical intervention or require medical intervention that is limited in scope
(i.e., non significant risk).
Examples include: Product failure requiring: reinsertion of a peripheral IV catheter, repeat skin injection (without impact to dose), peripheral
venous blood sampling, or one which results in clean (unused on patient, not contaminated) needle stick and/or blade injury, or which results in a
mild, non-painful electrical shock or first degree (superficial) burns.
3 Moderate Injury which may include significant discomfort, minor non-permanent injury and/or temporary disability. Symptoms are temporary and /or
reversible. These injuries usually require medical intervention to treat the injury. This category includes, but is not limited to:
• Injuries which require the need for minor, local surgery or the need to repeat a semi-invasive low-risk procedure due to product failure.
• The misdiagnosis or wrong treatment of a non-serious illness due to erroneous results
Examples include: Product failures resulting in fractured needle requiring local exploratory surgery to remove part, requiring reinsertion of a
central venous catheter, peripherally inserted central catheter, or invasive diagnostic procedure such as a spinal tap, or which results in a
contaminated sharps injury without seroconversion or transmission of blood borne disease, or which results in painful electrical shock, or second
degree (partial thickness) burns.

4 Severe Injury which results in severe symptoms, significant injury, potential long-term risk to health, or permanent impairment as a direct result of
product failure, or due to a delay in treatment as a result of product failure. The injury/symptoms may be irreversible despite medical interventio
but are not immediately life threatening. This category includes, but is not limited to:
• Injuries which require major or invasive (i.e., moderate to high-risk) surgery or other intervention for treatment, exposure of patient to a high
level of cumulative risk due to multiple medical interventions, or injuries which require patient hospitalization or which extend length of patient
hospitalization for treatment.
• The transmission or causation of a potentially chronically debilitating or life threatening disease as a result of the product malfunction
• The misdiagnosis or wrong treatment of a serious illness due to erroneous results
Examples include: product failures that require such procedures as exploratory laparotomy or other invasive diagnostic procedure with significant
risk, removal and reinsertion of a fully inserted pulmonary arterial catheter, or retrieval of catheter fragment from the heart. Also included are
product failures which result in loss of sight, amputation or loss of use of a limb, pneumonia, bacteremia, seroconversion for blood borne disease
such as HIV/AIDS or Hepatitis C, electrical exposure above the “let go” threshold but which does not result in cardiac or respiratory compromise,
or widespread partial thickness or limited full-thickness (third degree) burns.

5 Catastrophic Fatal or immediately life threatening. Fatal means death has already occurred. Life threatening means that death could occur in the near term
despite treatment or that the patient was or would be at immediate risk of death if medical intervention had not occurred.
Examples include: anaphylactic reaction, severe hemorrhage, cardiac tamponade, cardiac arrest, septic shock, electrocution with cardiac or
respiratory compromise, extensive third-degree burns.

Disclaimer:
The clinical examples in the above table are for guidance only. The severity ranking may change depending on a variety of factors, which need to be assessed on case by case basis.
 Risk Benefit Analysis
Document
No.: RM 370
Rev. No.: Rev. OS
Hypodermic Needle
Ref # Justification
Potential for leakage and exposure to SSP with seroconversion has a severity of 4. For the
identified risk, the occurrence is as low as possible (rank 1) which cannot be reduced any
RBA-1 further and there is a very low probability of this risk to occur. The current controls in place
demonstrate the acceptable performance of the device. The use of universal precautions
reduces this risk. Based on this assessment, the risk has been determined to be acceptable

) OtO:_ M ,
..Ll, ~ :JJN N, 2-0/ 7-
Author: Regina Haywood, RN, MSN, AN?
Associate Director, Medical Affairs fI Signature () Date

Approvals:

Prantosh Sivaya
Quality Manager

Bruce Culleton
VP WIN Medical Affairs
 EURA HISTORY
Rev. No. Revision Description ECO

1 Initial release in QDMS. ECO109416

Update Template per current version. Added "No" column.

Rows 2, 43 updated severity to 2, as severity will no longer be a 5, due to incorrect severity ranking of a 5 for this
effect of failure.
Added rows 12-15 due to MSS-14-450-SA.
Deleted "with treatable disease for effects of failure with seroconversion and deleted failure effects with
"seroconversion with non-treatable disease" due to new ranking criteria.
Added "None" for all under Recommended Actions. Deleted version tab.
Row 20, changed severity from 5 to 4, based on current ranking table.
Row 25 changed severity from 5 to 3 due to re-evaluation of potential risk from a needle poppiong off. Severity of 3
2 is considered worst case. 500000026927
Row 33 changed severity from 3 to 2. A NSI occurring from a needle that was removed from the patient has not
been in contact with blood/body fluids. The severity rating was changed to reflect risk from a non-contaminated
needle
Row 40 changed occurrence from 3 to 1, incorrectly classified originally (customer annoyance is specified in the
effect of failure, which is a 1).
Row 56 changed severity from 2 to 1, as this was incorrectly categorized in the previous version.
Deleted assumptions in 2, 20, 25, 33, 40, 43, 56 as they are no longer needed.
Assumption 1 - deleted "resulting in a risk category of "Acc/Inv", as it is not needed to specify.

Updated Template per current revision.

Updated to specify Products Affected from "Several, as applicable" to "Std/Conv Needles, SoloMed, Eclipse,
Microlance Needle, Discardit II, SafetyGlide Needle, Precision Glide Needle, Soloshot Mini, H1000 Needle"
Updated to include following risks from RM233 (dFMEA) to consolidate risks into one document:
- For the item Shield, revised potential cause of failure from: “Excessive interference, Incorrect material
formulation” to “Insufficient interference, Excessive lube, Incorrect material formulation”.
- For the item Cannula, a new Item function is added i.e.., Ability to draw from IV bag port/ septum after
penetration.
- For the item Epoxy, new potential failure mode is added i.e.., Assembly leaks.
- For item Epoxy, the following potential failure modes were removed due to being duplicate risks: 1. Clinician
annoyance. Cannula remains in patient. 2. Removal of cannula from patient. Clinician sustains a needle stick
injury. 3. Removal of cannula from patient. Clinician sustains a needle stick injury - seroconversion
- For item Hub, revised potential cause of failure from : “Incorrect Hub geometry” to “Hub/Thread geometry
incorrect for syringe”. Also revised potential effect of failure from “Difficulty aspirating medication. Clinician
annoyance” to “Difficulty aspirating medication. User annoyance”. Also added “TruLok Thread” as a current
3 design control. 500000036274
- For item Hub, revised potential cause of failure from : “Insufficient interference, Incorrect material formulation”
to “Insufficient interference, Excessive lube, Lube Migration, Incorrect material formulation”
- For the item Hub, a new potential effect of failure is added i.e.., Used needle falls out of shield during exchange
or disposal resulting in needle stick injury
- For the item Hub, removed potential effects of failure “Clinician has difficulty accessing septum due to high
penetration force”, "Damage to septum causing leakage - clinician is exposed to fluid /medication" and "Clinician
exposed to blood / bodily fluid - seroconversion"
- For the item Hub, removed potential effect of failure “Clinician exposed to blood / bodily fluid – seroconversion”
due to no blood/bodily fluid being present when penetrating a septum
Updated Source Ranking Criteria per MS-QS-034 Rev. 5
Added Risk Benefit Analysis (RBA) reference for appropriate risk items (i.e. Unacceptable risks)

Added Risk associated with the "Cannula Lube". Removed "Design Verification from the "Current Design Control"
column. dEURA RM370 Rev 03 was compared to RM233 FMEA to update the missing items. Removed
4 assumption as the listed occurrence accounts for WW data and added Note. 500000059957

• Consolidate RM754 into RM370 to avoid duplicacy of d-EURA per CAPA51679

• Updated to new template and Aligned Severity rating as per procedure MS-QS-034 Rev 04
5 • Update/Re-worded Item, Item function, Modes of failures, Cause of failure, Effect of failure, and Risk 500000093316
controls, as applicable throughout the document.
Revision Description ECO Number Version Prepared By
2.0 Revised Severity Ranking to align with CPR-033B ECO170594 Daniel Banner

B (3) Revised Ranking Criterions and formula to be in compliance with 500000024817 Ashlee Riden/
MS-QS-034 Rev 05. Shannon Kegel

Updated Ranking Criteria tab to specify Quantitative section on Risk

Evaluation Chart. Added a suggested Qualitative Table to Ranking
Criteria tab and corresponding definitions. Updated Column F
header from Current Design Controls to Risk Controls and updated
the header across columns F through I to read Existing Conditions.
Added Column O for RBA reference and added an RBA
C (4) Tab/Worksheet with examples and signature block. Updated 500000054887 Ryan Keller
conditional formatting for Risk Evaluation columns to enable auto-
color coding to Risk Evaluation Chart. Removed column L -
Responsibility & Status. Renamed Version History tab to Template
Version History and added a EURA Version History tab by
relocating the version history section from the EURA worksheet.
Other minor formatting updates throughout.