FDA Adverse Event
Malfunction
Summary report: N
11.5FR X 13.5CM MAHURKAR KIT
MDR report key: 2961079
·
Received January 17, 2013
Report
- Report Number
- 1317749-2013-00032
- Event Type
- Malfunction
- Date Received
- January 17, 2013
- Date of Event
- December 21, 2012
- Report Date
- January 3, 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
(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)(4) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES AFTER USING THE CATHETER FOR THREE MONTHS, THE ADAPTER WAS FOUND CRACKED. THE CATHETER WAS PULLED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 25631 | 11.5FR X 13.5CM MAHURKAR KIT | DIALYSIS CATHETER | MPB | COVIDIEN | 8813817005 | 031628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |