FDA Adverse Event
Injury
Summary report: N
MCKESSON DRAIN BAG
MDR report key: 1158689
·
Received September 11, 2008
Report
- Report Number
- 1650927-2008-00005
- Event Type
- Injury
- Date Received
- September 11, 2008
- Date of Event
- August 26, 2008
- Report Date
- September 10, 2008
- Manufacturer
- NURSE ASSIST, INC.
- Product Code
- KNX
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER REPORT 2 DRAW BAGS NOT FLOWING THROUGH INLET TUBING. RETURNED SAMPLES FUNCTIONALLY TESTED. ALL TESTS PASSED. THERE WAS NO RESTRICTION OF FLOW IN RETURNED SAMPLES. ADD'L LOT#: 801001. ADD'L EXP. DATE: 01/2011. ADD'L DEVICE MANUFACTURE DATE: 01/2008.
Description of Event or Problem · 1
DRAIN BAG INLET DID NOT FLOW CAUSING A BACKUP OF URINE, INFECTION POSSIBLY ASSOCIATED WITH BACKUP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MCKESSON DRAIN BAG | DRAIN BAG | KNX | NURSE ASSIST, INC. | 37-2801 | 701001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |