FDA Adverse Event
Other
Summary report: N
PALINDROME DIALYSIS CATHETER
MDR report key: 1011975
·
Received March 10, 2008
Report
- Report Number
- 1317749-2008-00038
- Event Type
- Other
- Date Received
- March 10, 2008
- Date of Event
- February 1, 2008
- Report Date
- February 10, 2008
- Manufacturer
- TYCO HEALTHCARE/KENDALL
- Product Code
- MPB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION IS UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL IN 2008 THAT A CUSTOMER HAD PROBLEM WITH A DIALYSIS CATHETER. THE CUSTOMER STATED PTS WITH PALINDROME CATHETERS HAVE EXPERIENCED CRACKED AND CHIPPED ADAPTERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PALINDROME DIALYSIS CATHETER | DIALYSIS CATHETER | MPB | TYCO HEALTHCARE/KENDALL | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |