BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A (INCIDENT OCCURRED IN THE WAREHOUSE)

    MDR report key: 1907847 · Received November 24, 2010

    Report

    Report Number
    1061932-2010-00228
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    CLASS1EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI MANUFACTURING HAS CONFIRMED THAT THERE IS NO OPPORTUNITY FOR BLOOD CONTACT DURING THE MANUFACTURING PROCESS (FILLING, CAPPING, LABELING, OR KIT PACKAGING) OF THE ZAP-OGLOBIN II LYTIC REAGENT. BLOOD CONTROLS AND CALIBRATORS MANUFACTURED AT (B)(4) ARE FILLED, CAPPED, LABELED, AND THE KITS PACKAGED AT SEPARATE BUILDINGS FROM WHERE THE REAGENT IS PRODUCED. INCOMING DEPARTMENT HAS INSPECTED SAMPLES FROM CURRENT INVENTORY AND NO LABELS EXHIBITED THE SPLATTERING MARKING ON THEM. SERVICE WAS NOT DISPATCHED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THEY FOUND A ZAP-OGLOBIN II LYTIC REAGENT CONTAINER THAT CONTAINED SPLATTERING RED MARKING, WHEN UNPACKING A SHIPMENT. THE CUSTOMER REPORTED POSSIBLE BLOOD SPLASHED ONTO THE PRODUCT LABELING. THE CUSTOMER REPORTED THAT SINCE THE LABEL WAS DRY WHEN FOUND, IT WAS PUT INTO A PLASTIC BAG BEFORE SCRAPPING IT. THE CUSTOMER CONFIRMED THAT THE OTHER PRODUCTS PACKED WITH THIS ITEM DID NOT HAVE THIS SYMPTOM. THERE WAS NO BLOOD EXPOSURE TO EYES, MOUTH, OR OPEN WOUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A (INCIDENT OCCURRED IN THE WAREHOUSE) N/A (INCIDENT OCCURRED IN THE WAREHOUSE) GKZ BECKMAN COULTER, INC. N/A 129012F

    Patients

    Seq Age Sex Outcome Treatment
    1