FDA Adverse Event
Other
Summary report: N
IN SWN NCK CRL CATH 39.1CM 2CF
MDR report key: 2969515
·
Received February 12, 2013
Report
- Report Number
- 1317749-2013-00069
- Event Type
- Other
- Date Received
- February 12, 2013
- Report Date
- January 23, 2013
- Manufacturer
- COVIDIEN
- Product Code
- FJS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 2013. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON 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 PERITONEAL DIALYSIS CATHETER. THE CUSTOMER STATES THE CATHETER WAS PLACED ON (B)(6) 2011 AND TWO HOLES DEVELOPED AND BOTH WERE REPAIRED. THE PT WAS PRESCRIBED ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 61030 | IN SWN NCK CRL CATH 39.1CM 2CF | PERITONEAL DIALYSIS CATHETER | FJS | COVIDIEN | 8888413100 | 809537 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |