BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH GREEN RUSCHLITE DISP MTL MAC 3.5

    MDR report key: 4451350 · Received January 23, 2015

    Report

    Report Number
    1044475-2015-00035
    Event Type
    Malfunction
    Date Received
    January 23, 2015
    Date of Event
    December 9, 2014
    Report Date
    January 5, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BLADE WAS RECEIVED WHILE STILL IN THE ORIGINAL PLASTIC PACKAGING. THE PLASTIC BASE WAS SHATTERED AS REPORTED WITH LOOSE PIECES OF HARD PLASTIC FLOATING IN THE PACKAGING. THE COMPLAINT HAS BEEN CONFIRMED, BUT A ROOT CAUSE CANNOT BE ESTABLISHED. NO CORRECTIVE/PREVENTIVE ACTIONS WILL BE ASSIGNED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE BLADE WAS RECEIVED BROKEN IN THE PACKAGE. PART OF THE BREAKAGE CONSISTED OF THE GREEN END BEING DISCONNECTED IN THE PACKAGE. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53711 RUSCH GREEN RUSCHLITE DISP MTL MAC 3.5 LARYNGOSCOPE BLADE CCW TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1