BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARCODE PACK

    MDR report key: 2550813 · Received April 19, 2012

    Report

    Report Number
    2550813
    Event Type
    Malfunction
    Date Received
    April 19, 2012
    Date of Event
    February 16, 2012
    Report Date
    April 18, 2012
    Manufacturer
    CARDINAL HEALTH
    Product Code
    EFQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RAYTEC WAS NOTED TO BE SOILED UPON OPENING OF A BURN PACK. A REDDISH-BROWN MATERIAL, APPROXIMATELY 2.5 IN X 2.5 IN SIZE WAS NOTED DRIED ON RAYTEC. THE BUNDLE OF RAYTEC WAS AT THE BOTTOM OF THE BURN PACK. NO OTHER FOREIGN MATERIAL WAS NOTED. THIS WAS OBSERVED BEFORE THE START OF THE CASE. THE BURN PACK WAS SEQUESTERED AND TAKEN TO THE CLINICAL CARE COORDINATOR.PRODUCT: BARCODE BURN PACK, SRIGF1055K, EXP 06/01/2012, MFG DATE 10/18/2011, ORDER # 047274.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARCODE PACK GAUZE, SPONGE EFQ CARDINAL HEALTH UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR