FDA Adverse Event
Malfunction
Summary report: N
RUSCH FOLEY CATHETER 100%SILICONE 2WAY 30CC 20
MDR report key: 2181600
·
Received July 6, 2011
Report
- Report Number
- 8040412-2011-00100
- Event Type
- Malfunction
- Date Received
- July 6, 2011
- Date of Event
- June 16, 2011
- Report Date
- June 22, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- EZL
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
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 UPON COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: "CUSTOMER STATED THAT THE CATHETER SLIPPED OUT OF THE PATIENT. MOSTLY THE CATHETER SLIPPED OUT OF THE PATIENT AT THE SECOND POSTOPERATIVE DAY." NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RUSCH FOLEY CATHETER 100%SILICONE 2WAY 30CC 20 | FOLEY CATHETER | EZL | TELEFLEX MEDICAL | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |