BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSPLIT XK BIOBLOC, 23CM

    MDR report key: 1222529 · Received November 6, 2008

    Report

    Report Number
    3006260740-2008-00189
    Event Type
    Injury
    Date Received
    November 6, 2008
    Report Date
    October 13, 2008
    Manufacturer
    C. R. BARD, INC. (BASD)
    Product Code
    MSD
    PMA / PMN Number
    K053589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE LINE WAS PLACED IN 2007, AND REMOVED IN 2008. WHEN THE CATHETER WAS REMOVED THE CUFF CAME OFF OF THE CATHETER AND STAYED IN THE PATIENT. A CUT DOWN PROCEDURE WAS DONE WHILE REMOVING THE CATHETER. MOST OF THE CUFF WAS REMOVED BUT THERE STILL IS A SMALL PORTION THAT REMAINS IN THE PATIENT'S SUBCUTANEOUS TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOSPLIT XK BIOBLOC, 23CM MSD C. R. BARD, INC. (BASD) RERE0046

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention