FDA Adverse Event
Malfunction
Summary report: N
RUSCH FOLEY CATHETERS, 2-WAY PEDIATRIC, 6FR
MDR report key: 2110009
·
Received May 16, 2011
Report
- Report Number
- 8040412-2011-00070
- Event Type
- Malfunction
- Date Received
- May 16, 2011
- Date of Event
- February 1, 2011
- Report Date
- April 28, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- KOD
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MFR AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT THE CATHETER SNAPPED MIDWAY DOWN THE CATHETER WITHOUT DECOMPRESSING THE BALLOON AND HAD TO BE REMOVED WITH FORCEPS. THERE WAS NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RUSCH FOLEY CATHETERS, 2-WAY PEDIATRIC, 6FR | FOLEY CATHETER | KOD | TELEFLEX MEDICAL | NA | 10DE14 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |