BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTILATION TUBE 7080100 HUNSAKER MON-JE

    MDR report key: 2467053 · Received February 24, 2012

    Report

    Report Number
    1045254-2012-00028
    Event Type
    Injury
    Date Received
    February 24, 2012
    Report Date
    January 30, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    BTR
    PMA / PMN Number
    K922880
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH 3500A FORM WAS RECEIVED FROM THE REPORTER. ANY MISSING OR INCOMPLETE DATA ON THIS FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROVIDED OR RELEASED BY THE REPORTER. ATTEMPTS TO OBTAIN THE REQUIRED INFORMATION WERE MADE, AND THE RECORDS OF THESE ATTEMPTS ARE DOCUMENTED IN THE COMPLAINT FILE. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. NEITHER THE DEVICE IN QUESTION, APPLICABLE IMAGING FILMS, OPERATING ROOM MEDICAL RECORDS WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE REPORT IS INCONCLUSIVE AS TO THE CAUSE OF THE REPORTED PRODUCT PROBLEM. IF THE DEVICE IS RETURNED IN THE FUTURE, PRODUCT ANALYSIS MAY BE PERFORMED. WITHOUT THE RECEIPT OF THE LOT # AND /OR THE SERIAL #, THE RETURN OF THE DEVICE SINCE INITIAL DISTRIBUTION CANNOT BE DETERMINED. THE INFORMATION REASONABLY SUGGESTS THAT A DEVICE IN QUESTION HAS MALFUNCTIONED AS DEFINED BY THE FDA . NO EVENT DATE PROVIDED. DEVICE DESCRIPTION: THE HUNSAKER MON-JET VENTILATION TUBE IS A SMALL DIAMETER, DUAL-LUMEN TRACHEAL TUBE. THE OVERALL LENGTH OF THE DEVICE IS APPROXIMATELY 33 CM, INCLUDING A POSITIONING STRUCTURE ON THE DISTAL END OF THE TUBE INTENDED TO MAINTAIN THE POSITION OF THE JET TUBE IN THE CENTRAL PORTION OF THE LUMEN OF THE TRACHEA. THE LARGER DIAMETER LUMEN OF THE TUBE IS INTENDED FOR THE INTERMITTENT JET VENTILATION DELIVERY OF OXYGEN. THE SMALLER DIAMETER TUBE LUMEN IS INTENDED TO BE CONNECTED TO A GAS MONITOR FOR MONITORING OF RESPIRATORY GASSES AND/OR AIRWAY PRESSURES. AN INTERNAL STAINLESS STEEL WIRE IS PROVIDED WITHIN THE LARGER LUMEN TUBE TO FACILITATE EXTUBATION IN THE EVENT OF LASER DAMAGE TO THE TUBE. BOTH THE JET TUBE AND THE MONITORING TUBE ARE FITTED ON THE PROXIMAL END WITH A LUER TYPE FITTING FOR CONNECTION TO OPERATING ROOM GAS SUPPLIES AND MONITORING EQUIPMENT. THE HUNSAKER MON-JET VENTILATION TUBE IS PROVIDED STERILE AND IS INTENDED FOR SINGLE USE ONLY. THE HUNSAKER MON-JET VENTILATION TUBE IS INTENDED TO BE USED AS A DEVICE FOR VENTILATING THE PATIENT BY THE ADMINISTRATION OF PRESSURIZED ANESTHESIA GASES, A TECHNIQUE REFERRED TO AS JET VENTILATION, IN MICROLARYNGEAL SURGICAL PROCEDURES.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE, THAT DURING A MICROLARYNGEAL SURGERY, THE TUBE BECAME OBSTRUCTED (POSSIBLY KINKED) TWO AND A HALF HOURS INTO THE PROCEDURE RESULTING IN DECREASED OXYGEN SATURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTILATION TUBE 7080100 HUNSAKER MON-JE TUBE, TRACHEAL (W/WO CONNECTOR) BTR MEDTRONIC XOMED, INC. 7080100 NOT PROVID

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention