FDA Adverse Event
Malfunction
Summary report: N
BARD
MDR report key: 1884920
·
Received October 21, 2010
Report
- Report Number
- MW5017911
- Event Type
- Malfunction
- Date Received
- October 21, 2010
- Date of Event
- October 21, 2010
- Report Date
- October 21, 2010
- Product Code
- KOD
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PHYSICIAN ATTEMPTED 2 FOLEY INSERTIONS AND GUIDE WIRE SNAPPED. ON THIRD INSERTION, GUIDE WIRE WAS REMOVED BEFORE CATHETER INSERTION. NO HARM TO PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BARD | PEDIATRIC FOLEY CATHETER | KOD | NGUF2549 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |