FDA Adverse Event
Death
Summary report: N
PALINDROME SAPPHIRE 23/40KT VT
MDR report key: 1439433
·
Received August 12, 2009
Report
- Report Number
- 1317749-2009-00188
- Event Type
- Death
- Date Received
- August 12, 2009
- Report Date
- July 21, 2009
- Manufacturer
- COVIDIEN
- Product Code
- MPB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WIL 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 DOWN THE SEAM LINE. THIS CATHETER WAS PULLED AND REPLACED WITH ANOTHER SAPPHIRE IN 2009. THIS PT PASSED AWAY, WITH THE NEWLY PLACED CATHETER IN PLACE, BUT THE CLINICIAN DID NOT FEEL THE CRACK HAD ANYTHING TO DO WITH THE PT'S DEATH. PT PASSED AWAY AT APPROXIMATELY 2 MONTHS LATER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PALINDROME SAPPHIRE 23/40KT VT | DIALYSIS CATHETER | MPB | COVIDIEN | 8888145048 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death |