FDA Adverse Event
Malfunction
Summary report: N
PALIND 23/40 SLOT SPRT W/VT
MDR report key: 1080612
·
Received July 17, 2008
Report
- Report Number
- 1317749-2008-00128
- Event Type
- Malfunction
- Date Received
- July 17, 2008
- Date of Event
- June 27, 2008
- Report Date
- June 30, 2008
- Manufacturer
- TYCO HEALTHCARE/KENDALL
- Product Code
- MPB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, 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 TYCO HEALTHCARE/KENDALL THAT A CUSTOMER HAD A PROBLEM WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THAT THE CATHETER WAS PLACED IN 2008. THE VENOUS ADAPTER CHIPPED AND WAS REPLACED AT APPROXIMATELY 44 DAYS LATER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PALIND 23/40 SLOT SPRT W/VT | DIALYSIS CATHETER | MPB | TYCO HEALTHCARE/KENDALL | 8888123404 | 714539 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |