BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2PC VSYS W/9FR INTR KIT LW PFL

    MDR report key: 4850180 · Received June 17, 2015

    Report

    Report Number
    1219930-2015-00479
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    May 25, 2015
    Report Date
    June 8, 2015
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    LJS
    PMA / PMN Number
    K961856
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: PORT-A IMPLANTATION. ACCORDING TO THE REPORTER: SHEATH MALFUNCTION. THE ISSUE WAS NOTICED PRIOR TO USE. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393474 2PC VSYS W/9FR INTR KIT LW PFL CATHETER INTRODUCER KIT LJS COVIDIEN, FORMERLY US SURGICAL A DIVISON 120021 N4G0223X

    Patients

    Seq Age Sex Outcome Treatment
    1