BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HICKMAN HEMODIALYSIS/APHERESIS 13.5 FR ROUND DUAL-LUMEN

    MDR report key: 1852070 · Received September 28, 2010

    Report

    Report Number
    3006260740-2010-00273
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 2, 2010
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K830233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NO INFORMATION

    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

    CATHETER HAS A HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HICKMAN HEMODIALYSIS/APHERESIS 13.5 FR ROUND DUAL-LUMEN LJS C. R. BARD INC. (BASD) REUE0605

    Patients

    Seq Age Sex Outcome Treatment
    1