FDA Adverse Event
Malfunction
Summary report: N
PEDIATRIC ULTRAMER CATHETER
MDR report key: 2843422
·
Received September 26, 2012
Report
- Report Number
- 2843422
- Event Type
- Malfunction
- Date Received
- September 26, 2012
- Date of Event
- April 19, 2012
- Report Date
- September 10, 2012
- Manufacturer
- COVIDIEN, FORMERLY KENDALL A DIVISION OF TYCO HEALTHCARE
- Product Code
- KOD
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
WHEN ATTEMPTING TO INSERT URINARY CATHETER, IT WAS NOTICED THAT THE CATHETER TIP DID NOT HAVE ANY DRAINAGE HOLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PEDIATRIC ULTRAMER CATHETER | PEDIATRIC ULTRAMER CATHETER | KOD | COVIDIEN, FORMERLY KENDALL A DIVISION OF TYCO HEALTHCARE | * | 1297282 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 MO | NO OTHER THERAPIES |