FDA Adverse Event
Other
Summary report: N
IN SWN NCK CRL CATH 38.9CM 2CF
MDR report key: 3592742
·
Received November 12, 2013
Report
- Report Number
- 1317749-2013-00364
- Event Type
- Other
- Date Received
- November 12, 2013
- Date of Event
- December 1, 2012
- Report Date
- October 31, 2013
- Manufacturer
- COVIDIEN
- Product Code
- FJS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION IS CURRENTLY UNDER WAY. UPON COMPLETION, THE INVESTIGATION RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THAT A PT (DOB APRIL 2009) HAD A CATHETER PLACED IN APRIL 2012. IT DEVELOPED A TEAR AT THE ADAPTER IN DECEMBER 2012. IT WAS REPAIRED. SHE HAD A SEVERE PERITONITIS, WHICH WAS TREATED WITH ANTIBIOTICS AND HAD CATHETER MALFUNCTION (PLUG), WHICH REQUIRED LAPAROSCOPIC REPAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 586576 | IN SWN NCK CRL CATH 38.9CM 2CF | DIALYSIS CATHETER | FJS | COVIDIEN | 8888413100 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |