/ University of Pittsburgh
B62 Benedum Hall
3700 O’Hara St.
Pittsburgh, PA 15261 / Redesign of a Safety Syringe
Doc. No.: FMECA-001 / Revision: 1
Date: 3/02/05 / Approval: QA Mgr.
FMECA
Redesign of a Safety Syringe
UNCONTROLLED UNLESS ISSUED WITH A RED STAMP
This document is the confidential property of S.A.F.E. Inc. and may not be reproduced without prior written consent. / STAMP HERE
APPROVED BY: / Signature: / DATE
Author / Jessica Chechak, Jason Keiser, Ellsworth Weatherby IV / 2/27/05
<Name>
Clinical / Ellsworth Weatherby IV / 2/27/05
<Name>
Engineering / Jason D. Keiser / 3/01/05
<Name>
Quality/Regulatory / Jason D. Keiser / 3/02/05
<Name>
Management / Jessica Chechak / 3/02/05
<Name>
<Other>
<Name
Change Record:
REV / DATE / DESCRIPTION OF CHANGE / AUTHORIZATION
0 / 9/16/04 / Initial Draft / QA Manager
1 / 3/02/05 / Revision 1 / QA Manager

Distribution List:

All project research personnel

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/ University of Pittsburgh
B62 Benedum Hall
3700 O’Hara St.
Pittsburgh, PA 15261 / Redesign of a Safety Syringe
Doc. No.: FMECA-001 / Revision: 1
Date: 3/02/05 / Approval: QA Mgr.

Purpose

The purpose of this document is to expand on the FMEA to include the probability and severity of each mode of failure.

Scope

This document is to be used to guide product related research and conceptual design development. It is not intended to serve as a formal product specification but to be used as a means of developing meaningful design input requirements for intended characteristics of the final product. This document will become part of the formal design history file and information derived from activities described herein may also result in design history file material.

The FMEA reveals any and all possible modes of failure for the device by function of component. The document breaks down these modes of failure by effect on the system, possible hazards arising from the failure, user detection means, the risk index and applicable controls for preventing this failure. The FMECA expands the FMEA to include the probability that each mode of failure will occur and the severity of each of these failures.

Revision History:

0.) Initial Draft

1.) Revision 1

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/ University of Pittsburgh
B62 Benedum Hall
3700 O’Hara St.
Pittsburgh, PA 15261 / Redesign of a Safety Syringe
Doc. No.: FMECA-001 / Revision: 1
Date: 3/02/05 / Approval: QA Mgr.
Function or Component / Failure Mode / Effect caused by Failure / Probability of Failure / Severity of Failure / Criticality Score / User Detection Means / Applicable Control(s)
Protective Cylinder Cap (Before Use) / Loose or missing / Needle may be exposed to Contaminants / 1 / 4 / 4 / Protective seal is damaged or removed / Protective plastic seal to ensure sterilization
Protective Cylinder Cap (Post Use) / Loose or missing / Contaminated Needle may become Exposed / 1 / 6 / 6 / The cap is missing or loose / Tighten cap securely after use
Syringe Needle / Needle damaged or unable to be attached to body / Syringe is unusable / 1 / 4 / 4 / If Needle is damaged or unable to be placed, Discard / Inspection During Production
Syringe Plunger / Failure to deliver substance / Syringe is unusable / 1 / 10 / 10 / If fluid is leaking or plunger will not depress, Discard / Inspection During Production
Movement of Protective Cylinder (Before Use) / Needle Damage / Syringe is unusable / 1 / 4 / 4 / If needle is damaged, Discard / Inspection During Production
Movement of Protective Cylinder (Post Use) / Cylinder does not stay locked around syringe / Contaminated needle may become exposed / 1 / 6 / 6 / If protective cylinder does not stay locked in place / Inspection During Production
Failure of Syringe Needle Retraction (After Use) / Needle does not retract into syringe / Contaminated needle will be exposed / 2 / 7 / 14 / The needle does not retract into the syringe after use / Inspection During Production
Protective Cylinder Push Mechanism / Protective cylinder does not slide up exposing the needle for use / Syringe is unusable / 1 / 4 / 4 / Protective cylinder prevents needle from being exposed for use / Inspection During Production

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