FDA Adverse Event
Malfunction
Summary report: N
PALINDROME 23/40 KIT W/ SLOT
MDR report key: 1952688
·
Received January 4, 2011
Report
- Report Number
- 1317749-2011-00003
- Event Type
- Malfunction
- Date Received
- January 4, 2011
- Date of Event
- December 6, 2010
- Report Date
- December 17, 2010
- Manufacturer
- COVIDIEN
- Product Code
- MSD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 2011. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A HEMODIALYSIS CATHETER. THE CUSTOMER REPORTS THE CATHETER WAS PLACED (B)(6) 2010 AND A LEAK WAS NOTICED ON THE (B)(6) 2010 ON THE DIALYSIS CATHETER, ON THE VENOUS SIDE ON THE EXTENSION. IT WAS REPLACED THE SAME DAY AND THE REPLACEMENT CATHETER HAS NOT GIVEN ANY PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PALINDROME 23/40 KIT W/ SLOT | HEMODIALYSIS CATHETER | MSD | COVIDIEN | 8888145015 | 020323 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |