BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC KIT

    MDR report key: 1963802 · Received December 22, 2010

    Report

    Report Number
    3006260740-2010-00383
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 14, 2010
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K034020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.

    Description of Event or Problem · 1

    DAMAGED CATHETER WAS FOUND. THE INDWELLING PERIOD WAS 62 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC KIT LJS C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention