FDA Adverse Event
Malfunction
Summary report: N
BARD ALL SILICONE FOLEY CATHETER LATEX FREE
MDR report key: 2151502
·
Received June 30, 2011
Report
- Report Number
- 2151502
- Event Type
- Malfunction
- Date Received
- June 30, 2011
- Report Date
- June 27, 2011
- Manufacturer
- CR BARD MEDICAL
- Product Code
- KOD
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
ON (B)(6) 2011 UROLOGISTS AT (B)(6) REPORTED THAT THE BARD ALL SILICONE FOLEY CATHETERS HAVE CAUSED PATIENT PROBLEMS. THE SILICONE CATHETERS HAVE A "LIP" SO THAT WHEN THE BALLOON IS DEFLATED FOR REMOVAL OF THE CATHETER, THE LIP CREATES A RIDGE THAT CAUSES PATIENTS TO HAVE PAIN, HEMATURIA AND TRAUMA. FOR EXAMPLE, THE CATHETER CAN BECOME ENCRUSTED WITH THE PATIENT'S TISSUE GROWING ON THE SITE, MAKING REMOVAL DIFFICULT. ALSO, THE CATHETERS APPEARS TO BE TOO STIFF CAUSING BLADDER SPASMS AND HEMATURIA. AS A RESULT, BARD SILICON FOLEY CATHETERS HAVE BEEN REMOVED FROM THE HOSPITAL SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BARD ALL SILICONE FOLEY CATHETER LATEX FREE | NONE | KOD | CR BARD MEDICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |