FDA Adverse Event
Injury
Summary report: N
POLYURETHANE URETERAL CATHETER
MDR report key: 1954612
·
Received December 17, 2010
Report
- Report Number
- 1018233-2010-00144
- Event Type
- Injury
- Date Received
- December 17, 2010
- Report Date
- November 18, 2010
- Manufacturer
- C.R. BARD, INC.
- Product Code
- EYB
- PMA / PMN Number
- PRE-AM
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE DIRECTIONS FOR USE STATES IN THE CAUTION SECTION: "DO NOT WITHDRAW URETERAL CATHETER WHILE IT IS DEFLECTED IN ENDOSCOPE. AVOID SHARP BENDING." (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT ON (B)(6), 2009, A PT HAD URETERAL CATHETERS PLACED DURING A SURGERY AND REMOVED AT THE END OF THE SURGERY. IN (B)(6) 2010, THE PT WAS FOUND TO HAVE A MICRO-HEMATURIA. AN X-RAY CONFIRMED THE PRESENCE OF A FOREIGN BODY. THE PT WAS TAKEN TO INTERVENTIONAL RADIOLOGY TO REMOVE AND RETAINED PORTION OF THE CATHETER. THE CATHETER PORTION MEASURED 10.5CM IN LENGTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLYURETHANE URETERAL CATHETER | EYB | C.R. BARD, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |