FDA Adverse Event
Malfunction
Summary report: N
600 ML TRANSFER BAG
MDR report key: 881676
·
Received July 15, 2007
Report
- Report Number
- MW5003044
- Event Type
- Malfunction
- Date Received
- July 15, 2007
- Report Date
- July 15, 2007
- Manufacturer
- CHARTER MEDICAL
- Product Code
- KSR
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DEFECTIVE CONNECTION OF TUBING TO NEEDLE ADAPTOR ON 600 ML BAGS. TWO DIFFERENT LOTS AFFECTS. FAULTY CONNECTION RESULTS IN LEAKS, THUS BAG INTEGRITY/STERILITY LOST. 600ML TRANSFER PACK, SLIPLOCK NEEDLE ADAPTOR AND 36" UNSEGMENTED TUBING LOT 113652, MANUFACTURE DATE 02/2007, EXPIRATION DATE: 2011-02, LOT 112334, MFR DATE NOT RECORDED, EXPIRATION DATE NOT RECORDED. DIAGNOSIS OR REASON FOR USE: PLASMA COLLECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 600 ML TRANSFER BAG | NONE | KSR | CHARTER MEDICAL | 113652 | ||
| 2 | 600ML TRANSFER BAG | NONE | KSR | CHARTER MEDICAL | 112334 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |