FDA Adverse Event
Other
Summary report: N
PALINDROME SAPPHIRE 23/40KT VT
MDR report key: 1920581
·
Received December 7, 2010
Report
- Report Number
- 1317749-2010-00327
- Event Type
- Other
- Date Received
- December 7, 2010
- Date of Event
- November 17, 2010
- Report Date
- November 24, 2010
- Manufacturer
- COVIDIEN
- Product Code
- MSD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
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 THAT A CUSTOMER HAD AN ISSUE WITH A HEMODIALYSIS CATHETER. THE CUSTOMER REPORTS THAT WHEN THE PT WAS GETTING DIALYSIS, THE PT MOVED IN HER BED TO USE A BASIN AND THE NURSE BECAME AWARE THAT THE CATHETER WAS ONLY ABOUT 1 INCH STILL IN THE PT. THE CATHETER NEEDED TO BE REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PALINDROME SAPPHIRE 23/40KT VT | HEMODIALYSIS CATHETER | MSD | COVIDIEN | 8888145048 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other |