FDA Adverse Event
Malfunction
Summary report: N
11.5FR X 13.5CM MAHURKAR KIT
MDR report key: 2963035
·
Received January 24, 2013
Report
- Report Number
- 1317749-2013-00047
- Event Type
- Malfunction
- Date Received
- January 24, 2013
- Date of Event
- January 17, 2013
- Report Date
- January 18, 2013
- Manufacturer
- COVIDIEN
- Product Code
- MPB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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 DIALYSIS CATHETER. THE CUSTOMER STATES THE CATHETER ADAPTER WAS FOUND CRACKED. THE CATHETER WAS IN USE FOR APPROX 3 MONTHS. THE CATHETER WAS PULLED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 34200 | 11.5FR X 13.5CM MAHURKAR KIT | DIALYSIS CATHETER | MPB | COVIDIEN | 8813817005 | 023812 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |