FDA Adverse Event
Malfunction
Summary report: N
PALIND 19 / 36 SLOT SPRT W / VT
MDR report key: 2980249
·
Received February 1, 2013
Report
- Report Number
- 1317749-2013-00062
- Event Type
- Malfunction
- Date Received
- February 1, 2013
- Date of Event
- December 3, 2012
- Report Date
- January 21, 2013
- Manufacturer
- COVIDIEN
- Product Code
- MSD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 2013. 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)(4) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER REPORTS THAT DURING THE DIALYSIS TREATMENT, THE NURSE NOTICED AIR IN THE TUBING AND BLOOD WAS DRAINING FROM ARTERIAL SIDE OF THE CATHETER. THE CATHETER WAS CLAMPED, TREATMENT STOPPED AND A CATHETER EXCHANGE WAS ORDERED. THE CATHETER WAS PLACED ON (B)(6) 2009, AND PULLED ON (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 45253 | PALIND 19 / 36 SLOT SPRT W / VT | DIALYSIS CATHETER | MSD | COVIDIEN | 8888119364 | 917081 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |