FDA Adverse Event
Summary report: N
BARDEX INFECTION CONTROL 400 SERIES TEMPERATURE-SENSING CATH
MDR report key: 2992480
·
Received February 21, 2013
Report
- Report Number
- 2992480
- Date Received
- February 21, 2013
- Date of Event
- February 19, 2013
- Report Date
- February 21, 2013
- Manufacturer
- C.R. BARD, INC.
- Product Code
- KOD
- Report Source
- User Facility report
- Reporter Location
- MN, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE PATIENT COMPLAINED OF PRESSURE IN ABDOMEN. URINE WAS LEAKING AROUND THE PATIENT'S CATHETER. THE CATHETER WAS REMOVED AND A NEW CATHETER WAS PLACED. THERE WAS 450ML OF URINE BACKED UP. THERE WAS NO ADVERSE EFFECT TO THE PATIENT. THE CATHETER WILL BE SENT TO BARD FOR INSPECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 75322 | BARDEX INFECTION CONTROL 400 SERIES TEMPERATURE-SENSING CATH | CATHETER | KOD | C.R. BARD, INC. | * | LP2028 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |