FDA Adverse Event
Malfunction
Summary report: N
PALINDROME 19/36 KIT W/ SLOT
MDR report key: 1924700
·
Received December 10, 2010
Report
- Report Number
- 1317749-2010-00330
- Event Type
- Malfunction
- Date Received
- December 10, 2010
- Report Date
- November 29, 2010
- Manufacturer
- COVIDIEN
- Product Code
- MSD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 2010. 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 STARTING TO RUN DIALYSIS ON A PT WHEN THE BACK VENOUS (BLUE) TUBING FELL OFF. IT WAS AS IF IT HAD BEEN CUT, HOWEVER, ALLEGEDLY NO STAFF HAD ACCESS TO SCISSORS. CATHETER HAD TO BE REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PALINDROME 19/36 KIT W/ SLOT | HEMODIALYSIS CATHETER | MSD | COVIDIEN | 8888145014 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |