FDA Adverse Event
Other
Summary report: N
PALIND 23/40 SLOT SPRT W/VT
MDR report key: 1023757
·
Received March 25, 2008
Report
- Report Number
- 1317749-2008-00047
- Event Type
- Other
- Date Received
- March 25, 2008
- Report Date
- March 7, 2008
- Manufacturer
- TYCO HEALTHCARE/KENDALL
- Product Code
- MPB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
PER SALES REP: "CATHETER WAS REPLACED". AN INVESTIGATION IS CURRENTLY UNDERWAY. 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. CUSTOMER STATED: "PALINDROME DIALYSIS CATHETER'S ADAPTER IS CRACKED, PT WILL BE SCHEDULED FOR AN EXCHANGE".
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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |