BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY CLR MURPHY CUF ET

    MDR report key: 16272875 · Received January 31, 2023

    Report

    Report Number
    8040412-2023-00025
    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). THE ACTUAL DEVICE WAS NOT RETURNED; HOWEVER, THE CUSTOMER RETURNED A DEVICE WITH A DIFFERENT LOT NUMBER. THE DEVICE WAS SENT TO THE MANUFACTURING SITE FOR EVALUATION. THE MANUFACTURING SITE REPORTS A VISUAL EXAM WAS PERFORMED AND NO DEFECTS OR ABNORMALITIES WERE FOUND. IN ADDITION, NO ISSUES WERE OBSERVED WITH THE CONNECTOR. THE INSERTION LENGTH AND DIAMETER MEASUREMENTS WERE ALSO TAKEN AND FOUND TO BE WITHIN SPECIFICATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE LOT NUMBER REPORTED BY THE CUSTOMER AND THE LOT NUMBER OF THE RETURNED SAMPLE. NO RELEVANT FINDINGS WERE IDENTIFIED. IT WAS ALSO REPORTED THAT "THE CONNECTOR ASSEMBLY FEATURES OF THE ENDOTRACHEAL TUBE WAS DESIGNED IN SUCH A WAY THAT THE CONNECTOR CAN BE REMOVED AND CONNECTED BACK TO THE TUBE WHEN THE TUBE IS REQUIRED TO BE CUT TO LENGTH. THERE IS PRECAUTION STATED IN THE DFU THAT THE 15MM CONNECTOR SHOULD BE FIRMLY SEATED IN THE TRACHEAL TUBE TO PREVENT DISCONNECTED DURING USE. BASED ON IFU, IT WAS MENTIONED THAT USES OF LUBRICATING SOLUTION TO EASE THE REINSERTION OF 15MM CONNECTOR IS NOT RECOMMENDED AS IT MAY CONTRIBUTE TO ACCIDENTAL DISCONNECTION." BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THE MANUFACTURING SITE REPORTS THAT ALL THE PRODUCT REQUIREMENTS AND DIMENSIONS MET SPECIFICATION. THE CONNECTOR ASSEMBLY FEATURES OF THE ENDOTRACHEAL TUBE WERE DESIGNED IN SUCH A WAY THAT THE CONNECTOR CAN BE REMOVED AND CONNECTED BACK TO THE TUBE WHEN THE TUBE IS REQUIRED TO BE CUT TO LENGTH. THERE IS A PRECAUTION STATED IN THE DFU THAT THE 15MM CONNECTOR SHOULD BE FIRMLY SEATED IN THE TRACHEAL TUBE TO PREVENT DISCONNECTED DURING USE.

    Additional Manufacturer Narrative · 0

    (B)(4). 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, 8040412-2023-00048, 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 ENDOTRACHEAL 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, 8040412-2023-00048, 8040412-2023-00049.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2105710 SAFETY CLR MURPHY CUF ET TUBE, TRACHEAL (W/WO CONNECTOR BTR IPN041502 KME21K1415 14026704341426

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown