FDA Adverse Event
Malfunction
Summary report: N
KIT 11.5FX19.5 CE MAHURKAR
MDR report key: 2940558
·
Received December 20, 2012
Report
- Report Number
- 1317749-2012-00345
- Event Type
- Malfunction
- Date Received
- December 20, 2012
- Date of Event
- November 10, 2012
- Report Date
- December 12, 2012
- Manufacturer
- COVIDIEN
- Product Code
- MSD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- 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) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER REPORTED THE CATHETER LEAKED AT THE Y JUNCTION. THE CATHETER WAS IMPLANTED ON (B)(6) 2012. IT WAS IN USE FOR 16 MONTHS AND 10 DAYS BEFORE THE FAILURE OCCURRED. THE CATHETER WAS PULLED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KIT 11.5FX19.5 CE MAHURKAR | DIALYSIS CATHETER | MSD | COVIDIEN | 8813793013 | 004028 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |