FDA Adverse Event
Malfunction
Summary report: N
ACTIFLO 4CM
MDR report key: 1923322
·
Received December 2, 2010
Report
- Report Number
- 1923322
- Event Type
- Malfunction
- Date Received
- December 2, 2010
- Date of Event
- November 29, 2010
- Report Date
- December 2, 2010
- Manufacturer
- HOLLISTER, INC.
- Product Code
- KNT
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- LA, US
Narratives
Description of Event or Problem · 1
AN ACTIFLO DEVICE WAS SET UP TO PLACE IN THE PT. THE BALLOON TO STOP THE FLOW OF STOOL WAS INFLATED WITH FIFTEEN CC OF AIR PER THE MFR'S RECOMMENDATION. THE BALLOON POPPED DURING INFLATION MAKING IT NON-USABLE. THIS IS THE SECOND OCCURRENCE THAT I AM AWARE OF WHERE THE BALLOON HAS POPPED PRIOR TO THE INSERTION IN THE PT. THE BALLOON WAS INFLATED WITH THE SYRINGE THAT WAS PROVIDED AND TO THE MFR'S INSTRUCTIONS. THE BALLOON SYSTEM WAS POSSIBLY DEFECTIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTIFLO 4CM | INDWELLING BOWEL CATHETER SYSTEM- 4CM | KNT | HOLLISTER, INC. | 32004 | OF12C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | NO OTHER THERAPIES |