BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY CLR MURPHY CUF ET

    MDR report key: 20123353 · Received September 3, 2024

    Report

    Report Number
    8040412-2024-00211
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Date of Event
    July 16, 2024
    Report Date
    August 7, 2024
    Manufacturer
    TELEFLEX MEDICAL SDN. BHD.
    Product Code
    BTR
    UDI-DI
    14026704341426
    PMA / PMN Number
    K961837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. 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: " 7.0 TELEFLEX CUFFED ETT CAUSE SOFT TISSUE TRAUMA TO THE AIRWAY DUE TO THEIR STIFFNESS. THE CUFFS ARE NOT IDEAL.".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: " 7.0 TELEFLEX CUFFED ETT CAUSE SOFT TISSUE TRAUMA TO THE AIRWAY DUE TO THEIR STIFFNESS. THE CUFFS ARE NOT IDEAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699637 SAFETY CLR MURPHY CUF ET TUBE, TRACHEAL (W/WO CONNECTOR BTR TELEFLEX MEDICAL SDN. BHD. 40E23H3765 14026704341426

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED.| NOT REPORTED.