FDA Adverse Event
Injury
Summary report: N
CAREFUSION PLEURX KIT
MDR report key: 3503591
·
Received December 3, 2013
Report
- Report Number
- MW5033277
- Event Type
- Injury
- Date Received
- December 3, 2013
- Date of Event
- November 21, 2013
- Report Date
- December 2, 2013
- Manufacturer
- CAREFUSION
- Product Code
- DWM
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
YUEH NEEDLE SHEATH SHEARED OFF IN THE PT. A GOOSENECK TYPE SNARE DEVICE WAS UTILIZED TO CAPTURE THE SEARED OFF PIECE. THE PT REQUIRED NO F/U RELATED TO THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 624627 | CAREFUSION PLEURX KIT | YUEH NEEDLE SHEATH | DWM | CAREFUSION | REF. # 50-9000B | 0000551042 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |