FDA Adverse Event
Malfunction
Summary report: N
PALINDROME SAPPHIRE 19/36KT VT
MDR report key: 1487394
·
Received August 11, 2009
Report
- Report Number
- 1317749-2009-00184
- Event Type
- Malfunction
- Date Received
- August 11, 2009
- Report Date
- July 21, 2009
- Manufacturer
- COVIDIEN
- Product Code
- MPB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: 08/10/2009. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON 07/21/2009 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. CUSTOMER STATES THAT THE ADAPTER CRACKED AND HAD TO BE PULLED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PALINDROME SAPPHIRE 19/36KT VT | DIALYSIS CATHETER | MPB | COVIDIEN | 8888145057 | 544498 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |