FDA Adverse Event
Summary report: N
BARDEX INFECTION CONTROL 400 SERIES TEMPERATURE-SENSING FOLE
MDR report key: 2982042
·
Received February 19, 2013
Report
- Report Number
- 2982042
- Date Received
- February 19, 2013
- Date of Event
- February 11, 2013
- Report Date
- February 19, 2013
- Manufacturer
- C.R. BARD, INC.
- Product Code
- MJC
- Report Source
- User Facility report
- Reporter Location
- MN, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE PATIENT HAD A THERMISTOR CATHETER INSERTED WHILE IN THE EMERGENCY DEPARTMENT. APPROXIMATELY 50 HRS AFTER INSERTION, THERE WAS A DECREASE IN URINE OUTPUT. THE NURSE DISCUSSED WITH THE PHYSICIAN THAT URINE OUTPUT HAS BEEN OLIGURIC. THE PATIENT WAS GIVEN A 500CC NORMAL SALINE BOLUS FOR DECREASED URINE OUTPUT. THE NURSE WAS PERFORMING AN ASSESSMENT AND OBSERVED THAT THE PATIENT HAD A FIRM AND DISTENDED ABDOMEN (OVER THE BLADDER AREA). THERE WAS URINE LEAKING AROUND THE CATHETER. THE THERMISTOR CATHETER WAS REMOVED AND REPLACED WITH A NEW REGULAR FOLEY. THERE WAS AN IMMEDIATE RETURN OF 1400ML AMBER/BROWNISH-TINGED URINE. THE CATHETER WAS DRAINING WITHOUT DIFFICULTY. NO ADVERSE OUTCOME TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 72188 | BARDEX INFECTION CONTROL 400 SERIES TEMPERATURE-SENSING FOLE | CATHETER | MJC | C.R. BARD, INC. | 129416M | DJ2240 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |