BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CBCII BLOOD CONSERVATION KIT W/1/4 INCH ROUND PVC WOUND DRAIN

    MDR report key: 2955102 · Received February 11, 2013

    Report

    Report Number
    0001811755-2013-00256
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    CAC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION BECAUSE IT WAS DISCARDED. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLUE TRANSFER BUTTON ON THE DEVICE BROKE OFF WHEN PRESSED. BLOOD WAS NOT ABLE TO BE TRANSFERRED INTO THE BLOOD BAG; 400 CC OF BLOOD WAS DISCARDED. THE PATIENT RECEIVED 1 UNIT OF BAGGED BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59370 CBCII BLOOD CONSERVATION KIT W/1/4 INCH ROUND PVC WOUND DRAIN APPARATUS, AUTOTRANSFUSION CAC STRYKER INSTRUMENTS-KALAMAZOO 12249012

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention