BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2PC VSYS/PRT/LOCKS 4NDL LW PFL

    MDR report key: 2885855 · Received November 16, 2012

    Report

    Report Number
    1219930-2012-00937
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    March 23, 2012
    Report Date
    October 22, 2012
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GCJ
    PMA / PMN Number
    K952748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE SHARP EDGE LOCKER CAUSED CATHETER FRACTURE. THE PT WAS INVOLVED WITHOUT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2PC VSYS/PRT/LOCKS 4NDL LW PFL INFUSION PORT GCJ COVIDIEN, FORMERLY US SURGICAL N8A298

    Patients

    Seq Age Sex Outcome Treatment
    1