FDA Adverse Event
Malfunction
Summary report: N
IN SWN NCK CRL CATH 39.1CM 2CF
MDR report key: 891257
·
Received August 8, 2007
Report
- Report Number
- 1317749-2007-00073
- Event Type
- Malfunction
- Date Received
- August 8, 2007
- Date of Event
- June 1, 2007
- Report Date
- July 23, 2007
- Manufacturer
- COVIDIEN
- Product Code
- FJS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
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 THAT A CUSTOMER HAD A PROBLEM WITH A DIALYSIS CATHETER. THE CUSTOMER STATED, THAT THE PD CATHETER WAS PLACED IN PATIENT, WHEN THEY TRIED TO USE THE CATHETER A COUPLE OF DAYS LATER IT DID NOT WORK SO THEY HAD TO REPEAT THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IN SWN NCK CRL CATH 39.1CM 2CF | DIALYSIS CATHETER | FJS | COVIDIEN | 8888413100 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |