BEUDAMED
    FDA Adverse Event Summary report: N

    WET PVP-1 PREOPERATIVE SKIN PREP TRAY

    MDR report key: 2171873 · Received July 20, 2011

    Report

    Report Number
    2171873
    Date Received
    July 20, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 20, 2011
    Manufacturer
    CAREFUSION CORP
    Product Code
    KXF
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    WE ARE REPORTING ON A PRODUCT LOOK-A-LIKE ISSUE. CAREFUSION MAKES TWO SKIN PREP TRAYS THAT ARE HARD TO DISTINGUISH BETWEEN THE TWO. ONE IS THE WET PVP-1 PREOPERATIVE SKIN PREP TRAY CATALOGUE# 4468 AND THE OTHER IS THE WET PVP-1 VAGINAL PREOPERATIVE SKIN PREP TRAY CATALOGUE #4469-A. THE COLOR AND SIZE IS THE SAME FOR BOTH PACKAGES. WE HAVE EXPERIENCED SEVERAL EVENTS WHERE THE SCRUB NURSE HAS GRABBED AND OPENED THE WRONG PACKAGE BECAUSE THEY LOOK THE SAME. TO DATE, WE HAVE NOT HAD ANY PATIENT RELATED INJURY OR TROUBLE, HOWEVER, THESE SKIN PREP TRAYS ARE QUITE EXPENSIVE AND WASTE HAS OCCURRED BECAUSE ONCE A PACKAGE IS OPENED, IT CANNOT BE USED AGAIN AND IS DISCARDED. PICTURES ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WET PVP-1 PREOPERATIVE SKIN PREP TRAY SKIN PREP TRAY KXF CAREFUSION CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *