FDA Adverse Event
Malfunction
Summary report: N
SWAN NECK TNCKHOFF SN T2 LFT
MDR report key: 2030788
·
Received March 22, 2011
Report
- Report Number
- 1317749-2011-00101
- Event Type
- Malfunction
- Date Received
- March 22, 2011
- Date of Event
- March 9, 2011
- Report Date
- March 16, 2011
- Manufacturer
- COVIDIEN
- Product Code
- FJS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 2011. 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) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A PERITONEAL DIALYSIS CATHETER. THE NURSE STATES THE PT HAS USED THE CATHETER FOR NEARLY 4YRS. NURSE DISCOVERED THAT THERE WAS PIN SIZE HOLE NEAR THE SKIN AREA. THIS CAUSED PERITONEAL INFLAMMATION REQUIRING ANTIBIOTIC THERAPY. CATHETER WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SWAN NECK TNCKHOFF SN T2 LFT | PERITONEAL DIALYSIS CATHETER | FJS | COVIDIEN | 8888412007 | 702228 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |