FDA Adverse Event
Malfunction
Summary report: N
FOLY CATH 3-WAY 30CC 22FR
MDR report key: 1062176
·
Received June 13, 2008
Report
- Report Number
- 1282497-2008-00016
- Event Type
- Malfunction
- Date Received
- June 13, 2008
- Report Date
- June 10, 2008
- Manufacturer
- TYCO HEALTHCARE/KENDALL
- Product Code
- KOD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION, THE RESULTS WILL BE FORWARD.
Description of Event or Problem · 1
IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL ON 06/10/2008 THAT A CUSTOMER HAD A PROBLEM WITH A UROLOGY CATHETER. THE CUSTOMER STATED THAT THE CATHETER TIP BROKE OFF IN THE PT. IT BROKE BELOW THE BOTTOM EYELIT. THE PT REQUIRED MEDICAL INTERVENTION TO REMOVE THE BROKEN PIECE, THAT WAS IN THE PATIENT'S BLADDER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FOLY CATH 3-WAY 30CC 22FR | UROLOGY CATHETER | KOD | TYCO HEALTHCARE/KENDALL | 8887665225 | 7295135 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |