FDA Adverse Event
Malfunction
Summary report: N
PALIND 19/36 SLOT SPRT W/VT
MDR report key: 1030429
·
Received April 16, 2008
Report
- Report Number
- 1317749-2008-00064
- Event Type
- Malfunction
- Date Received
- April 16, 2008
- Report Date
- March 21, 2008
- Manufacturer
- TYCO HEALTHCARE/KENDALL
- Product Code
- MPB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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 REPORTED THAT THEY HAD TO EXCHANGE A PALINDROME DIALYSIS CATHETER BECAUSE OF A CRACKED ADAPTER. PER DISCUSSION WITH THE DIALYSIS NURSE, SHE SAID THAT SHE TOOK A CAP OFF OF THE ADAPTER AND THE ADAPTER "CRUMBLED" INTO SEVERAL PIECES. THE PT WAS SENT TO THE HOSPITAL FOR AN EXCHANGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PALIND 19/36 SLOT SPRT W/VT | DIALYSIS CATHETER | MPB | TYCO HEALTHCARE/KENDALL | 8888119364 | 734511 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |