FDA Adverse Event
Malfunction
Summary report: N
AIR CHARGED CATHETERS
MDR report key: 4924526
·
Received June 3, 2015
Report
- Report Number
- 4924526
- Event Type
- Malfunction
- Date Received
- June 3, 2015
- Date of Event
- May 29, 2015
- Report Date
- June 3, 2015
- Manufacturer
- LABORIE MEDICAL TECHNOLOGIES, CORP
- Product Code
- KOD
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- UT, US
Narratives
Description of Event or Problem · 1
FAULTY URODYNAMIC BLADDER CATHETER, READING 300+ PRESSURES, CHECKED PRESSURES AS RECOMMENDED PRIOR TO INSERTION OF CATHETER AND THEY WERE APPROPRIATE (TROUBLESHOOTING PERFORMED PER RECOMMENDATION FROM LABORIE) REMOVED FAULTY CATHETER AND REPLACED WITH NEW ONE. THIS IS THE 3RD EVENT WE HAVE ENCOUNTERED LIKE THIS. WE BELIEVE 2 OR 3 LOT NUMBERS ARE INVOLVED. IN THE 2 PRIOR EVENTS, THE DEFECTIVE CATHETERS AND PULLED LOT NUMBERS WERE SENT TO LABORIE FOR FURTHER TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 360929 | AIR CHARGED CATHETERS | URINARY CATHETER | KOD | LABORIE MEDICAL TECHNOLOGIES, CORP | * | 141228 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | NOT SPECIFIED |