BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENAX LASER RESISTANT ENDOTRACHEAL TUBE

    MDR report key: 18002828 · Received October 25, 2023

    Report

    Report Number
    18002828
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    October 12, 2023
    Report Date
    October 12, 2023
    Manufacturer
    BRYAN MEDICAL, INC.
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PRIOR TO OUR CASE, WE TESTED MULTIPLE ANESTHESIA LASER TUBES, AND THEY WERE NOT WORKING PROPERLY, THE DISTAL NOT INFLATING ON ONE AND THE PROXIMAL NOT INFLATING ON THE OTHER, THE CUFF WAS NOT INFLATING PROPERLY. WE DID A FURTHER DIVE AND NOTICED THE LOT NUMBER ON THE BOX IS NOT THE SAME AS THE LOT NUMBER ON THE ACTUAL PACKAGE, THIS IS REGARDING THE TENAX LASER RESISTANT ENDOTRACHEAL TUBE KIT. HOWEVER, ONE OF THE TUBES DID WORK BUT IT STILL HAD THE SAME LOT NUMBER AS THE ONES NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1433877 TENAX LASER RESISTANT ENDOTRACHEAL TUBE TUBE, TRACHEAL (W/WO CONNECTOR) BTR BRYAN MEDICAL, INC. TG0060 1206320C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown