BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2PC VSYS W/9FR INTR KIT LW PFL

    MDR report key: 3416061 · Received September 9, 2013

    Report

    Report Number
    1219930-2013-00757
    Event Type
    Malfunction
    Date Received
    September 9, 2013
    Date of Event
    August 12, 2013
    Report Date
    August 16, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    LJT
    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: THERE WAS AN ABNORMAL SPLIT IN THE INTRODUCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449063 2PC VSYS W/9FR INTR KIT LW PFL CHEMOSITE INTRODUCER KIT LJT COVIDIEN, FORMERLY US SURGICAL N0C0788

    Patients

    Seq Age Sex Outcome Treatment
    1