BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY CLR MURPHY CUF ET

    MDR report key: 16272685 · Received January 31, 2023

    Report

    Report Number
    8040412-2023-00048
    Event Type
    Malfunction
    Date Received
    January 31, 2023
    Date of Event
    January 10, 2023
    Report Date
    January 18, 2023
    Manufacturer
    TELEFLEX MEDICAL SDN. BHD.
    Product Code
    BTR
    UDI-DI
    14026704341426
    PMA / PMN Number
    K961837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. 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. OTHER REMARKS: N/A.

    Additional Manufacturer Narrative · 0

    (B)(4). N/A. OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Description of Event or Problem · 0

    IT IS REPORTED THAT "ON MULTIPLE OCCASIONS, WHILE IN THE MIDDLE OF A SURGICAL CASE, THE DETACHABLE PLASTIC PIECE ON THE TOP OF THE E NDOTRACHEAL TUBE HAS COME OFF COMPLETELY WITH THE CIRCUIT ATTACHED WHILE THE PATIENT IS INTUBATED. LAST WEEK THIS HAPPENED TWICE IN THE MIDDLE OF OUR FIRST CASE." AFTER FURTHER CORRESPONDENCE WITH THE REPORTER, THE CUSTOMER DOES NOT HAVE ANY FURTHER INFORMATION REGARDING THE SPECIFICS OF THE EVENTS. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED. SEE ASSOCIATED MDRS 8040412-2023-00046, 8040412-2023-00047, 8040412-2023-00025, AND 8040412-2023-00049.

    Description of Event or Problem · 0

    IT IS REPORTED THAT "ON MULTIPLE OCCASIONS, WHILE IN THE MIDDLE OF A SURGICAL CASE, THE DETACHABLE PLASTIC PIECE ON THE TOP OF THE E NDOTRACHEAL TUBE HAS COME OFF COMPLETELY WITH THE CIRCUIT ATTACHED WHILE THE PATIENT IS INTUBATED. LAST WEEK THIS HAPPENED TWICE IN THE MIDDLE OF OUR FIRST CASE." AFTER FURTHER CORRESPONDENCE WITH THE REPORTER, THE CUSTOMER DOES NOT HAVE ANY FURTHER INFORMATION REGARDING THE SPECIFICS OF THE EVENTS. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED. SEE ASSOCIATED MDRS 8040412-2023-00046, 8040412-2023-00047, 8040412-2023-00025, 8040412-2023-00049.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2005439 SAFETY CLR MURPHY CUF ET TUBE, TRACHEAL (W/WO CONNECTOR BTR IPN041502 KME21J0756 14026704341426

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown