BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY CLR MURPHY CUF ET

    MDR report key: 20123319 · Received September 3, 2024

    Report

    Report Number
    8040412-2024-00209
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Date of Event
    July 12, 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).

    Additional Manufacturer Narrative · 0

    QN#(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS PROVIDED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THEREFORE, THE POTENTIAL CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT A SAMPLE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "7.0 ET IS TOO HARD , RIGID, NOT COMPLIANT WITH PT'S TISSUE, INCREASED RISK OF TRAUMA OR BLEEDING IN THE ORAL AIRWAY." THE ISSUE WAS IDENTIFIED PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "7.0 ET IS TOO HARD , RIGID, NOT COMPLIANT WITH PT'S TISSUE, INCREASED RISK OF TRAUMA OR BLEEDING IN THE ORAL AIRWAY." THE ISSUE WAS IDENTIFIED PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1832988 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