FDA Adverse Event
Malfunction
Summary report: N
STERIS QUICK CONNECT
MDR report key: 346804
·
Received August 9, 2001
Report
- Report Number
- MW1022606
- Event Type
- Malfunction
- Date Received
- August 9, 2001
- Date of Event
- August 6, 2001
- Report Date
- August 9, 2001
- Manufacturer
- STERIS CORP NO. AMERICAN HEALTHCARE DIV.
- Product Code
- MLR
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- VT, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
ADD'L INFO REC'D FROM MFR 09/17/01: A DESIGN CHANGE WAS IMPLEMENTED TO IMPROVE THE MANUFACTURING AND RELIABILITY OF THE ADAPTER. THE DESIGN CHANGE INCLUDED THE ADDITION OF THREADS ON BOTH THE ADAPTER CAP AND ADAPTER BODY. THE THREADS ALLOW FOR A MORE COMPLETE JOINING OF THE TWO PARTS. THE DESIGN CHANGE DOE NOT RAISE NEW QUESTIONS OF SAFETY OR EFFICACY, NOR ALTER THE FUNCTION OF THE ADAPTER. ALL QLC 1629 QUICK CONNECTS MANUFACTURED SINCE MID-AUGUST 2001 INCORPORATE THIS DESIGN CHANGE. STERIS CORPORATION HAS NOT RECEIVED ANY COMPLAINTS REGARDING FAILURES OF QUICK CONNECT ADAPTERS WITH THE NEW DESIGN.
Description of Event or Problem · 1
PRODUCT CAME APART DURING THE STERILIZATION PROCESS. THIS WAS THE THIRD TIME THIS HAS OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 35999 | STERIS QUICK CONNECT | CONNECTING DEVICE | MLR | STERIS CORP NO. AMERICAN HEALTHCARE DIV. | * | QLC1629 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |