BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSTAR BIOBLOC, 19CM

    MDR report key: 1230852 · Received November 6, 2008

    Report

    Report Number
    3006260740-2008-00191
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    April 21, 2008
    Report Date
    October 13, 2008
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    MSD
    PMA / PMN Number
    K053589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.

    Description of Event or Problem · 1

    DIALYSIS CENTER CALLED FRANTIC ABOUT THE PT'S DIALYSIS CATHETER BURST DURING DIALYSIS. THEY CLAMPED IT WITH HEMOSTATS AND SENT THE PT TO THE FACILITY RIGHT AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOSTAR BIOBLOC, 19CM MSD C. R. BARD INC. (BASD) RERI0278

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention