FDA Adverse Event
Summary report: N
PLEURX
MDR report key: 2873429
·
Received December 4, 2012
Report
- Report Number
- 2873429
- Date Received
- December 4, 2012
- Date of Event
- November 7, 2012
- Report Date
- December 4, 2012
- Manufacturer
- CAREFUSION
- Product Code
- KDQ
- Report Source
- User Facility report
- Reporter Location
- TN, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
THREE BOXES OF CAREFUSION PLEURX PLEURAL CATHETER KITS WERE RECEIVED AT THE FACILITY. THE OUTER CARDBOARD BOX HOUSING THE TRAYS WAS LABELED 50-9000B. THE SLEEVE OF THE INDIVIDUAL TRAYS (UNITS INSIDE THE CARDBOARD HOUSING) WAS LABELED 50-7000B. THE LABEL DISCREPANCY WAS COMMUNICATED TO THE MANUFACTURER AND THE DEVICES WERE PREPARED FOR RETURN TO THE COMPANY (SEE ASSOCIATED PICTURE SENT VIA E-MAIL). THE PACKAGING WAS NOT OPENED BY THE FACILITY SO CONTENTS COULD NOT BE VERIFIED. THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLEURX | APPARATUS, SUCTION, PATIENT CARE | KDQ | CAREFUSION | 50-7000B | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |