BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ISIS SUBGLOTTIC SEC. ET TUBE

    MDR report key: 2960542 · Received January 23, 2013

    Report

    Report Number
    3003898360-2013-00035
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION COULD NOT BE CONDUCTED SINCE THE DEVICE SAMPLE WAS NOT RETURNED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. THE COMPLAINT CAN NOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE PURPLE PIECE WHERE THE SUCTION ACCESSORY ATTACHES TO THE ISIS ENDOTRACHEAL TUBE CAME UNGLUED FROM THE TUBE WHILE IN USE ON A PT. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32992 HUDSON ISIS SUBGLOTTIC SEC. ET TUBE ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1