BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2PC VSYS W/9FR INTR KIT LW PFL

    MDR report key: 3178913 · Received June 4, 2013

    Report

    Report Number
    1219930-2013-00415
    Event Type
    Malfunction
    Date Received
    June 4, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 14, 2013
    Manufacturer
    COVIDIEN LP, FORMERLY US SUR
    Product Code
    LJT
    PMA / PMN Number
    K961856
    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

    PROCEDURE: CHEMOSITE INSERTION. ACCORDING TO THE REPORTER: AN ABNORMAL SPLIT SHEATH OCCURRED IN THE INTRODUCER. NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247578 2PC VSYS W/9FR INTR KIT LW PFL INFUSION PORT LJT COVIDIEN LP, FORMERLY US SUR N1C0208;

    Patients

    Seq Age Sex Outcome Treatment
    1