FDA Adverse Event
Malfunction
Summary report: N
PALINDROME 23/40 KIT W/ SLOT
MDR report key: 2883811
·
Received November 16, 2012
Report
- Report Number
- 1317749-2012-00288
- Event Type
- Malfunction
- Date Received
- November 16, 2012
- Date of Event
- October 22, 2012
- Report Date
- November 5, 2012
- Manufacturer
- COVIDIEN
- Product Code
- MSD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(6) 2012. 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) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER REPORTS THAT THERE WERE BUBBLES DURING SUCTION ON THE ARTERIAL WAY OF THE CATHETER. AFTER CHECKING, THE OPERATOR NOTICED A CRACK OF APPROXIMATELY 2-3 MM. THE CATHETER WAS REMOVED ON (B)(6) 2012. IT HAD BEEN APPLIED ON (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PALINDROME 23/40 KIT W/ SLOT | DIALYSIS CATHETER | MSD | COVIDIEN | 8888145015 | 121724X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |