BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGT NASAL CUFFED ET 7.0MM

    MDR report key: 22791981 · Received August 13, 2025

    Report

    Report Number
    8040412-2025-00195
    Event Type
    Malfunction
    Date Received
    August 13, 2025
    Date of Event
    July 17, 2025
    Report Date
    July 17, 2025
    Manufacturer
    TELEFLEX MEDICAL SDN. BHD.
    Product Code
    BTR
    UDI-DI
    14026704341228
    PMA / PMN Number
    K931164
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. THE CUSTOMER SUPPLIED PHOTO ONLY SHOWS THE PRODUCT PACKAGING PHOTO AND DOES NOT PROVIDE SUFFICIENT DETAIL REGARDING THE COMPLAINT EVENT DESCRIPTION WHICH IS CUFF LEAKED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE, THE COMPLAINT COULD NOT BE CONFIRMED, AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE CUFF WILL NOT HOLD AIR, PRIOR TO USE. NO PATIENT INVOLVED.".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE CUFF WILL NOT HOLD AIR, PRIOR TO USE. NO PATIENT INVOLVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814436 AGT NASAL CUFFED ET 7.0MM TUBE, TRACHEAL (W/WO CONNECTOR BTR TELEFLEX MEDICAL SDN. BHD. 40E24J2548 14026704341228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.| N/A.