BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CBC II-(3/16" KIT) PKG/6 WORLD

    MDR report key: 1791538 · Received July 23, 2010

    Report

    Report Number
    2648666-2010-00317
    Event Type
    Malfunction
    Date Received
    July 23, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 8, 2010
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    CAC
    PMA / PMN Number
    K952224
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AT THE ACCOUNT. A LOT NUMBER WAS NOT GIVEN FOR THIS COMPLAINT, SO A DEVICE HISTORY RECORD COULD NOT BE REVIEWED. IF ADDITIONAL INFO IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE OF THE TRANSFUSION FILTER BROKE OFF IN THE BLOOD BAG. THE APPROXIMATELY 500 CCS OF COLLECTED BLOOD COULD NOT BE RE-INFUSED. IT IS UNK IF THE PT RECEIVED A BLOOD TRANSFUSION FROM EITHER A BLOOD BANK OR PRE-DONATED BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBC II-(3/16" KIT) PKG/6 WORLD AUTOTRANSFUSION APPARATUS CAC STRYKER INSTRUMENTS PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK