FDA Adverse Event
Summary report: N
UNK DY
MDR report key: 1033546
·
Received April 23, 2008
Report
- Report Number
- 1317749-2008-00067
- Date Received
- April 23, 2008
- Date of Event
- March 17, 2008
- Report Date
- March 25, 2008
- Manufacturer
- TYCO HEALTHCARE/KENDALL
- Product Code
- MPB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION IS CURRENTLY UNDER WAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO TYCO HEALTH CARE/KENDALL IN 2008 THAT A CUSTOMER HAD A PROBLEM WITH A DIALYSIS CATHETER. THE CUSTOMER STATED THAT A DIALYSIS CATHETER ADAPTER CRACKED AND CATHETER NEEDED TO BE EXCHANGED. THE PRODUCT NAME AND CODE FOR THIS CATHETER IS UNK, BUT THE CUSTOMER STATED THAT IT WAS A 23CM CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK DY | DIALYSIS CATHETER | MPB | TYCO HEALTHCARE/KENDALL | UNK DY | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |