FDA Adverse Event
Malfunction
Summary report: N
RUSCH 100% SILICONE FOLEY 6 FR
MDR report key: 3243094
·
Received July 18, 2013
Report
- Report Number
- 8040412-2013-00129
- Event Type
- Malfunction
- Date Received
- July 18, 2013
- Date of Event
- July 1, 2013
- Report Date
- July 3, 2013
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- KOD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
SAMPLE RECEIVED BY MFR, BUT INVESTIGATION IS INCOMPLETE AT TIME OF THIS REPORT.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: ALLEGED ISSUE: CATHETER WAS INSERTED INTO PT AND AFTER A FEW MINUTES THE CATHETER WAS LEAKING. WHEN THE STAFF CHECKED OUT THE LEAKING, THEY FOUND THAT THE CATHETER HAD BROKEN FROM THE TUBING AT THE Y CONNECTOR. NO REPORTED PT INJURY. PT CONDITION REPORTED AS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 335557 | RUSCH 100% SILICONE FOLEY 6 FR | FOLEY CATHETER | KOD | TELEFLEX MEDICAL | 12JE45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |