BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENAX LASER RESISTANT ENDOTRACHEAL TUBE

    MDR report key: 15079437 · Received July 20, 2022

    Report

    Report Number
    MW5111040
    Event Type
    Malfunction
    Date Received
    July 20, 2022
    Date of Event
    April 27, 2022
    Report Date
    July 19, 2022
    Manufacturer
    BRYAN MEDICAL, INC.
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    INTERVENTION WAS REQUIRED TO DEFLATE ENDOTRACHEAL TUBE CUFFS AND EXTUBATE PATIENT. PATIENT WAS INTUBATED. A LEAK WAS IDENTIFIED. ANESTHESIOLOGIST INSERTED MORE SALINE INTO CUFFS BECAUSE IT WAS LEAKING. AS MORE SALINE WAS INSERTED, THE ENTIRE CIRCUMFERENCE OF THE ENDOTRACHEAL TUBE BEGAN TO FILL WITH AIR/SALINE. THE ANESTHESIOLOGIST WAS UNABLE TO REMOVE THE SALINE SO THE SURGEON AND THE ANESTHESIOLOGIST POKED A HOLE IN THE SIDE OF THE TUBE TO REMOVE THE LIQUID AND EXTUBATE THE PATIENT. REPORT IS BEING MADE OUT OF AN ABUNDANCE OF CAUTION DUE TO SURGICAL INTERVENTION. IT IS NOT BELIEVED THAT DEFECT WOULD HAVE LEAD TO SERIOUS HARM OR DEATH. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88508 TENAX LASER RESISTANT ENDOTRACHEAL TUBE TUBE, TRACHEAL (W/WO CONNECTOR) BTR BRYAN MEDICAL, INC. TG0070 1110111D

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown