FDA Adverse Event
Malfunction
Summary report: N
RUSCH 100% SILICONE FOLEY 6 FR
MDR report key: 3193098
·
Received June 21, 2013
Report
- Report Number
- 8040412-2013-00102
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Date of Event
- June 1, 2013
- Report Date
- June 3, 2013
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- KOD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
NO SAMPLE IS AVAILABLE FOR THE MANUFACTURER TO EVALUATE.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: THE CATHETER BROKE AT THE FUNNEL WITH THE BALLOON STILL INSIDE PATIENT AND WILL BE SURGICALLY REMOVED AFTER HE HAS RECOVERED FROM ORIGINAL SURGICAL PROCEDURE. PATIENT WAS RE-CATHETERIZED WITHOUT PROBLEM. REQUESTED ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283574 | RUSCH 100% SILICONE FOLEY 6 FR | FOLEY CATHETER | KOD | TELEFLEX MEDICAL | 12KE46 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |