BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 FR S/L POWERPICC SOLO FULL TRAY

    MDR report key: 3042965 · Received March 7, 2013

    Report

    Report Number
    3006260740-2013-00095
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K091324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    WIRE TIED IN KNOT DURING PLACEMENT OF .017 WIRE IN VEIN FOR ACCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98428 4 FR S/L POWERPICC SOLO FULL TRAY LJS C. R. BARD INC. (BASD) REWK0576

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention