BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENAX

    MDR report key: 19491422 · Received June 7, 2024

    Report

    Report Number
    3005803389-2024-00001
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Report Date
    June 7, 2024
    Manufacturer
    BRYAN MEDICAL, INC.
    Product Code
    BTR
    PMA / PMN Number
    K200761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND IT WAS FOUND THAT THE DEVICE WAS CORRECTLY MANUFACTURED ACCORDING TO ALL REQUIREMENTS AND SPECIFICATIONS. THE DOCTOR DID NOT MAKE A REPORT TO BRYAN MEDICAL OF THE PRODUCT BEING FAULTY. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED

    Description of Event or Problem · 0

    ORIGINAL REPORTING: WHILE SURGEONS WERE TRYING TO INSTRUMENT THE AREA AROUND THE VOCAL CORDS IT WAS NOTED THAT THE TUBE KEPT COLLAPSING, WHICH RESULTED IN BRIEF EPISODES OF INCREASED AIRWAY PRESSURE. 6.5MM I.D. X 10MM O.D. (30FR). ADDITIONAL NARRATIVE RECEIVED 05/29: A SIZE 6 LASER TUBE WAS USED. AS THEY WERE TRYING TO GET A VIEW TO START LASERING THE TUBE WAS KINKING VERY EASILY. WE CONTINUED TO MAKE ENT AWARE, THEY WOULD MOVE THEIR EQUIPMENT TO RELIEVE THE PRESSURE POINT BUT AS THE CASE PROCEEDED THE ETT BECAME MORE PLIABLE - LIKELY SECONDARY TO HEAT. AT THAT POINT I CAME IN THE ROOM AND WITNESSED THE ETT KINKING PROXIMAL TO THE LASER TAPING BUT DISTAL TO THE CONNECTOR FOR THE CIRCUIT. IT WAS VERY DIFFICULT TO MAINTAIN THE SHAPE, IT WAS WANTING TO BEND AND KINK ON ITS OWN. OBVIOUSLY, AN OBSTRUCTION IN THE ETT SUCH AS THIS PUT THE PATIENT AT SIGNIFICANT RISK FOR NEGATIVE PRESSURE PULMONARY EDEMA, AS THE SITUATION IS AKIN TO INSPIRATION AGAINST A CLOSED GLOTTIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2124841 TENAX TENAX LASER RESISTANT ENDOTRCHEAL TUBE BTR BRYAN MEDICAL, INC. TG0065-S 1502409D

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown