BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL PACK AV GRAFT PACK

    MDR report key: 3493708 · Received October 23, 2013

    Report

    Report Number
    3493708
    Event Type
    Malfunction
    Date Received
    October 23, 2013
    Date of Event
    October 23, 2013
    Report Date
    October 23, 2013
    Manufacturer
    CARDINAL HEALTH 200, INC.
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    OPERATING ROOM (OR) SCRUB NURSES WERE SETTING UP FOR THE NEXT CASE AND BEGAN TO COUNT SPONGES PRE-CASE. DEBRIS WAS FOUND EMBEDDED WITHIN A SPONGE. ENTIRE SET-UP WAS TAKEN DOWN AND DISPOSED OF. CARDINAL PACK WAS AV GRAFT PK (B)(4) & LOT NUMBER 23661. A SECOND SET-UP WAS BEGUN AND THEN THE SPONGES WITHIN THE CARDINAL PAK CONTAINED DEBRIS. CARDINAL PACK WAS THE AV GRAFT PACK (B)(4) W/ LOT # 236611. A THIRD SET-UP WAS ATTEMPTED, BUT BROWN SPECKS (DEBRIS) WAS WOVEN INTO THE SPONGES. THIS WAS A DIFFERENT LOT, BUT WAS THE CARDINAL PACK AV GRAFT PACK (B)(4), LOT # 231685. ====================== MANUFACTURER RESPONSE FOR CARDINAL PACK SPONGES, CARDINAL PACK AV GRAFT PACK (PER SITE REPORTER) ====================== ALL AV GRAFT PACKS HAVE BEEN PULLED FROM THE SHELVES IN THE OPERATING ROOM. THE LOT # 236611 WAS BROUGHT TO THE OR SUPERVISOR'S ATTENTION AND THE SUPERVISOR WAS LATER MADE AWARE OF THE SECOND LOT # 231685. THE OR SUPERVISOR CONTACTED THE CARDINAL HEALTH TO DETERMINE IF OTHER LOTS WERE AVAILABLE TO SEND OVER TO OUR FACILITY. THE OR MEANWHILE BEGAN ASSEMBLING THEIR OWN KITS UNTIL CARDINAL CAN CREATE A NEW BATCH OF SPONGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543319 CARDINAL PACK AV GRAFT PACK SURGICAL SPONGE PACK GDY CARDINAL HEALTH 200, INC. * 236611

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR NOT APPLICABLE - THE OR ROOM WAS BEING SET UP AT T| HE TIME IN ANTICIPATION OF A PENDING OR CASE