FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN DY
MDR report key: 2231073
·
Received July 20, 2011
Report
- Report Number
- 1317749-2011-00213
- Event Type
- Malfunction
- Date Received
- July 20, 2011
- Date of Event
- August 1, 2010
- Report Date
- June 29, 2011
- Manufacturer
- COVIDIEN
- Product Code
- MPB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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 CUSTOMER REPORTS PT HY HAD A DOUBLE CUFF CURL CATHETER INSERTED (B)(6) 2008 AND DEVELOPED A HOLE JUST BELOW THE ADAPTER (B)(6) 2010. THE PT WAS GIVEN ANTIBIOTICS AND DID NOT DEVELOP PERITONITIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DY | PERITONEAL DIALYSIS CATHETER | MPB | COVIDIEN | UNK DY | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |