FDA Adverse Event
Malfunction
Summary report: N
RUSCH 6FR 100% SILICONE FOLEY 1
MDR report key: 2241465
·
Received August 17, 2011
Report
- Report Number
- 8040412-2011-00123
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- August 10, 2011
- Report Date
- August 11, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- EZL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: ALLEGED ISSUE: WHEN ATTEMPTING TO INSERT THE CATHETER, IT WAS NOTED THAT THE STYLETTE WAS POKING THROUGH THE SHEATH OF THE CATHETER ITSELF. THE INSERTION WAS UNSUCCESSFUL AND CATHETER HAD TO BE REMOVED. NO PATIENT INJURY REPORTED. PATIENT CURRENT CONDITION IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RUSCH 6FR 100% SILICONE FOLEY 1 | FOLEY CATHETER | EZL | TELEFLEX MEDICAL | 11CE13 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |