BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE MAJOR PACK

    MDR report key: 2211047 · Received August 5, 2011

    Report

    Report Number
    2211047
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    CARDINAL HEALTH
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    THE STAFF WERE OPENING A MAJOR PACK PREPARING FOR THE CASE; THE TEAM DISCOVERED THAT THE NON X-RAY DETECTABLE SPONGES WERE PACKAGED IN BLUE WRAP AS IF THEY WERE X-RAY DETECTABLE SPONGE (RAYTECS) AND VICE VERSA. THESE SPONGES ARE INTENDED TO BE SEGREGATED FOR SAFETY. THIS IS A POTENTIAL RISK TO THE PATIENT. THIS WAS DISCOVERED BEFORE THE PATIENT ENTERED THE ROOM, AS THE TEAM WAS SETTING UP. ======================MANUFACTURER RESPONSE FOR MAJOR SURGERY STERILE GOODS PACK, STERILE MAJOR PACK (PER SITE REPORTER)======================THEY ARE LOOKING INTO THE CAUSE OF THE MIX-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERILE MAJOR PACK MAJOR SURGERY STERILE GOODS PACK LRO CARDINAL HEALTH * (ORDER # 048529)

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES