FDA Adverse Event
Malfunction
Summary report: N
BARD¿ LATEX-FREE DRAINAGE BAG FOLEY
MDR report key: 1731836
·
Received June 8, 2010
Report
- Report Number
- 1731836
- Event Type
- Malfunction
- Date Received
- June 8, 2010
- Date of Event
- June 7, 2010
- Report Date
- June 8, 2010
- Manufacturer
- BARD MEDICAL DIVISION
- Product Code
- KOD
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NY, US
Narratives
Description of Event or Problem · 1
A BARD FOLEY CATHETER WAS INSERTED IN A PATIENT. THE BALLOON DEFLATED AND THE CATHETER NEEDED TO BE REPLACED. THERE WAS NO HARM TO THE PATIENT. IT WAS NOTED THAT OVER THE WEEKEND THERE WERE SEVERAL PROBLEMS WITH THESE PARTICULAR CATHETER BALLOONS DEFLATING. THE CATHETER TRAYS BEING USED WERE BARD PRODUCT #907216, LATEX-FREE DRAINAGE BAG FOLEY TRAY WITH ANTI-REFLUX CHAMBER DRAINAGE BAG, IN SIZE 16FR. TWO LOT NUMBERS WERE IDENTIFIED AS PROBLEMS: NGUC1924 AND NGUD1854. IN ADDITION, TWO OTHER LOT NUMBERS WERE SUSPECTED OF HAVING SIMILAR PROBLEMS. THESE WERE LOT NUMBERS NGUC0365 AND NGUD1853. THE BALLOON ON THE CATHETER LEAKED AND DEFLATED, CAUSING THE CATHETER TO HAVE TO BE REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BARD¿ LATEX-FREE DRAINAGE BAG FOLEY | CATHETER, FOLEY, TRAY | KOD | BARD MEDICAL DIVISION | * | NGUC1924 | |
| 2 | BARD¿ LATEX-FREE DRAINAGE BAG FOLEY TRAY WITH ANTI-REFLUX CH | CATHETER, FOLEY, TRAY | KOD | BARD MEDICAL DIVISION | * | NGUD1854 | |
| 3 | BARD¿ LATEX-FREE DRAINAGE BAG FOLEY | CATHETER, FOLEY, TRAY | KOD | BARD MEDICAL DIVISION | * | NGUC0365 | |
| 4 | BARD¿ LATEX-FREE DRAINAGE BAG FOLEY | CATHETER, FOLEY, TRAY | KOD | BARD MEDICAL DIVISION | * | NGUD1853 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |