BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTED HEMOSPLIT BIOBLOC CATHETER

    MDR report key: 2190829 · Received July 15, 2011

    Report

    Report Number
    3006260740-2011-00228
    Event Type
    Injury
    Date Received
    July 15, 2011
    Report Date
    July 11, 2011
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    MSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    THE HEMOSPLIT BIOBLOC FRACTURED BELOW THE CUFF. ADDITIONAL INFORMATION: THE PATIENT HAD TO HAVE SURGERY TO RETRIEVE THE HALF THAT WAS LEFT INSIDE AND IT TRAVELED TO THE HEART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTED HEMOSPLIT BIOBLOC CATHETER BLOOD ACCESS AND ACCESSORIES MSD C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention