BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD

    MDR report key: 3810829 · Received March 21, 2014

    Report

    Report Number
    3006260740-2014-00129
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    February 21, 2014
    Report Date
    February 24, 2014
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    MSD
    PMA / PMN Number
    K030020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WIL BE EVALUATED. RESULT ARE EXPECTED SOON.

    Description of Event or Problem · 1

    WHEN UNPACKING THE KITS, IT WAS NOTICED A SLIT WAS IN ONE OF THE KITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169145 HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD MSD C.R. BARD, INC. (BASD) REXK1717

    Patients

    Seq Age Sex Outcome Treatment
    1