FDA Adverse Event
Malfunction
Summary report: N
11.5FR X 13.5CM MAHURKAR KIT
MDR report key: 2960995
·
Received January 15, 2013
Report
- Report Number
- 1317749-2013-00034
- Event Type
- Malfunction
- Date Received
- January 15, 2013
- Date of Event
- November 22, 2012
- Report Date
- January 3, 2013
- Manufacturer
- COVIDIEN LP
- Product Code
- MPB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER REPORTS AFTER BEING USED FOR APPROXIMATELY 45 DAYS, THE ADAPTER CRACKED AND ERRHYSIS OCCURRED DURING HEMODIALYSIS. THE CATHETER WAS PULLED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 21974 | 11.5FR X 13.5CM MAHURKAR KIT | DIALYSIS CATHETER | MPB | COVIDIEN LP | 8813817005 | 0238 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |