FDA Adverse Event
Malfunction
Summary report: N
KIT 11.5FX19.5CM MAHURRKAR
MDR report key: 2961077
·
Received January 17, 2013
Report
- Report Number
- 1317749-2013-00030
- Event Type
- Malfunction
- Date Received
- January 17, 2013
- Date of Event
- December 29, 2013
- Report Date
- December 31, 2012
- Manufacturer
- COVIDIEN
- Product Code
- LFJ
- 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 THE ADAPTER WAS FOUND CRACKED. THE DEVICE WAS USED FOR LESS THAN THREE MONTHS. THE CATHETER WAS PULLED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 26721 | KIT 11.5FX19.5CM MAHURRKAR | DIALYSIS CATHETER | LFJ | COVIDIEN | 8813793009 | 131518X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |