FDA Adverse Event
Other
Summary report: N
IN SWN NCK CRL CATH 38.9CM 2CF
MDR report key: 3592750
·
Received November 12, 2013
Report
- Report Number
- 1317749-2013-00363
- Event Type
- Other
- Date Received
- November 12, 2013
- Date of Event
- February 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. UP COMPLETION, THE 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 ((B)(6)) HAD A DIALYSIS CATHETER PLACED IN (B)(6) 2011. IT DEVELOPED A HOLE AT THE ADAPTER AND WAS REPAIRED WITH A TITANIUM ADAPTER IN (B)(6) 2012. SHE RECEIVED PROPHYLACTIC ANTIBIOTIC. THE CATHETER DEVELOPED ANOTHER TEAR AT THE ADAPTER IN (B)(6) 2012. IT WAS AGAIN REPAIRED AND SHE AGAIN RECEIVED ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 586521 | IN SWN NCK CRL CATH 38.9CM 2CF | DIALYSIS CATHETER | FJS | COVIDIEN | 8888413100 | 809537 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |