FDA Adverse Event
Malfunction
Summary report: N
RUSCH 100% SILICONE FOLEY 6 FR
MDR report key: 3231986
·
Received July 15, 2013
Report
- Report Number
- 8040412-2013-00126
- Event Type
- Malfunction
- Date Received
- July 15, 2013
- Date of Event
- June 4, 2013
- Report Date
- June 28, 2013
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- KOD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
SAMPLE HAS NOT BEEN RECEIVED BY MFR IN TIME FOR THIS REPORT.
Description of Event or Problem · 1
EVENT REPORTED AS: PT WAS HAVING A URINARY CATHETER PLACED FOR VUCG TESTING. THEY HAD MADE 3 ATTEMPTS (THREE SEPARATE CATHETERS) TO PLACE CATHETER AND WERE UNSUCCESSFUL. THE NURSE PRACTITIONER ATTEMPTED TO PLACE CATHETER. SHE LOOSENED GUIDE WIRE AND PULLED BACK SLIGHTLY. THE CATHETER STILL COULD NOT BE ADVANCED. SHE WITHDREW THE CATHETER. WHEN SHE WITHDREW SHE SAW THAT THE GUIDE WIRE HAD GONE THROUGH THE SIDE OF THE CATHETER. A NEW SMALLER SIZED CATHETER WAS PLACED. THE TEST COMPLETED. NO PT HARM OR INTERVENTION WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 327666 | RUSCH 100% SILICONE FOLEY 6 FR | FOLEY CATHETER | KOD | TELEFLEX MEDICAL | 13AE02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |