BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2PC VSYS/PRT/LOCKS 4NDL LW PFL

    MDR report key: 3557087 · Received November 12, 2013

    Report

    Report Number
    1219930-2013-00988
    Event Type
    Malfunction
    Date Received
    November 12, 2013
    Date of Event
    October 29, 2013
    Report Date
    October 29, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    LJT
    PMA / PMN Number
    K952748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE CHEMOTHERAPY CATHETER RUPTURED AFTER 2 YEARS. PT INVOLVED WITHOUT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584711 2PC VSYS/PRT/LOCKS 4NDL LW PFL CHEMOSITE PORT LJT COVIDIEN, FORMERLY US SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1