BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTED POWER HICKMAN

    MDR report key: 3800559 · Received February 11, 2014

    Report

    Report Number
    3006260740-2014-00047
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Report Date
    January 27, 2014
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, AS THE DEVICE WAS DISCARDED AFTER REMOVAL. 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

    POWER HICKMAN PRODUCT CAUSING FIBRIN SHEATHS. NO OTHER INFO PROVIDED. CONSERVATIVELY REPORTING AS A MALFUNCTION DUE TO THE RISK THAT THE FIBRIN SHEATH DETACH FROM THE VEIN WALL AND EMBOLIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90325 IMPLANTED POWER HICKMAN CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM LJS C.R. BARD, INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention