BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLOSURE FAST

    MDR report key: 2926581 · Received January 18, 2013

    Report

    Report Number
    2926581
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 18, 2013
    Manufacturer
    COVIDIEN, FORMERLY VNUS MEDICAL TECHNOLOGIES
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE PACKAGING WAS OPENED ONTO THE STERILE FIELD, THE SURGEON BEGAN INSERTING DEVICE IN VEIN AND FOUND A KINK MID WAY IN CATHETER. CATHETER WAS REMOVED AND ANOTHER PROVIDED. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27232 CLOSURE FAST ELECTROSURGICAL, CUTTING & COAGULATION GEI COVIDIEN, FORMERLY VNUS MEDICAL TECHNOLOGIES 7F60CM 551515

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR NO OTHER THERAPIES