FDA Adverse Event
Malfunction
Summary report: N
36CM PERM CATH KIT X5
MDR report key: 2489656
·
Received March 8, 2012
Report
- Report Number
- 1317749-2012-00062
- Event Type
- Malfunction
- Date Received
- March 8, 2012
- Date of Event
- February 17, 2012
- Report Date
- February 17, 2012
- Manufacturer
- COVIDIEN
- Product Code
- LFJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- NURSE
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) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THE CATHETER LEAKS, AS SMALL HOLES WERE DISCOVERED ON ITS VEINAL END. PATIENT WAS INVOLVED BUT WITH NO INJURY. THE CATHETER WAS PULLED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 36CM PERM CATH KIT X5 | DIALYSIS CATHETER | LFJ | COVIDIEN | 8817748001 | 026628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |