FDA Adverse Event
Malfunction
Summary report: N
36CM PERM CATH KIT X5
MDR report key: 3842470
·
Received February 20, 2014
Report
- Report Number
- 1317749-2014-00104
- Event Type
- Malfunction
- Date Received
- February 20, 2014
- Date of Event
- February 12, 2014
- Report Date
- February 12, 2014
- Manufacturer
- COVIDIEN
- Product Code
- MSD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
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) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THAT THE CATHETER WAS INSERTED IN THE PT TWO MONTHS AGO. THE PHYSICIAN FOUND THAT THE ARTERIAL SIDE ADAPTER WAS BROKEN. THE CATHETER WAS PULLED AND REPLACED WITH A NEW ONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 106880 | 36CM PERM CATH KIT X5 | DIALYSIS CATHETER | MSD | COVIDIEN | 8817748001 | 213801X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |