FDA Adverse Event
Malfunction
Summary report: N
PALIDROME EMERALD 28/45 KIT VT
MDR report key: 3221799
·
Received July 2, 2013
Report
- Report Number
- 1317749-2013-00212
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- June 3, 2013
- Report Date
- June 7, 2013
- Manufacturer
- 0COVIDIEN
- Product Code
- MPB
- 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
THE CUSTOMER STATES THAT ONE OF THE ADAPTERS SPINS AROUND WITHIN THE EXTENSION TUBING. THERE WAS O PT INJURY OR ILL EFFECT. THE CATHETER WAS PULLED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 300951 | PALIDROME EMERALD 28/45 KIT VT | DIALYSIS CATHETER | MPB | 0COVIDIEN | 8888145045 | 925437 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |