BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ET TUBE, SHER-I-BRONCH, LS, 37 FR

    MDR report key: 19700391 · Received July 9, 2024

    Report

    Report Number
    3003898360-2024-00788
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    May 20, 2024
    Report Date
    June 11, 2024
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CBI
    PMA / PMN Number
    K180253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). UDI NUMBER: (B)(4). THE CUSTOMER RETURNED ONE UNIT 5-16037 ET TUBE, SHER-I-BRONCH, LS, 37 FR FOR INVESTIGATION. ONE REPRESENTATIVE SAMPLE WAS RETURNED. AN ACTUAL SAMPLE WAS NOT RETURNED. THE REPRESENTATIVE SAMPLE WAS VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE SAMPLE APPEARS TYPICAL. NO DEFECTS OR ANOMALIES WERE OBSERVED. A FUNCTIONAL INSPECTION WAS PERFORMED TO ATTEMPT TO INFLATE AND DEFLATE THE BALLOON CUFFS ON THE RETURNED ET TUBE. A SYRINGE WAS FILLED WITH AIR AND ATTACHED TO THE VALVE OF THE TRACHEAL (WHITE) PILOT BALLOON. UPON INJECTION OF AIR, BOTH THE PILOT BALLOON AND CUFF IMMEDIATELY INFLATED. THE SAME PROCESS WAS USED TO TEST THE BRONCHIAL (BLUE) INFLATION LINE. ONCE AGAIN, BOTH THE PILOT BALLOON AND CUFF IMMEDIATELY INFLATED. THE SYRINGE WAS THEN REMOVED, AND THE CUFFS AND PILOT BALLOONS WERE INSPECTED FOR LEAKS. NO LEAKS WERE DETECTED. THE SYRINGE WAS THEN REATTACHED IN ORDER TO DEFLATE THE BALLOONS. ALL PILOT BALLOONS AND BALLOON CUFFS WERE ABLE TO DEFLATE. THE ET TUBE WAS SUBMER GED UNDERWATER AND AN ATTEMPT TO INFLATE THE BALLOON CUFFS WAS MADE IN ORDER TO DETECT ANY LEAKS. UPON INJECTION OF AIR, NO LEAKS WERE DETECTED. NO FUNCTIONAL ISSUES WERE FOUND WITH THE RETURNED SAMPLE. THE IFU FOR THIS PRODUCT WAS REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. THE IFU STATES, "THE CUFF INFLATION SYSTEM (CUFFS, PILOT BALLOONS, VALVES) SHOULD BE CHECKED BY INFLATION AND DEFLATION PRIOR TO USE. IF CUFF IS DAMAGED, THE TUBE SHOULD NOT BE USED. CARE SHOULD BE TAKEN TO AVOID DAMAGING THE CUFFS DURING INTUBATION. IF ANY ONE OF THE CUFFS IS DAMAGED, THE TUBE SHOULD NOT BE USED." "CUFF PRESSURE SHOULD BE MONITORED ROUTINELY TO ASSURE THAT AN ADEQUATE SEAL IS MAINTAINED AND THAT THE CUFFS HAVE NOT BECOME OVER-INFLATED." "DEFLATE ALL CUFFS PRIOR TO REPOSITIONING THE TUBE. MOVEMENT OF THE TUBE WITH CUFFS INFLATED COULD RESULT IN PATIENT INJURY OR IN DAMAGE TO THE CUFFS, REQUIRING A TUBE CHANGE. VERIFY THE POSITION OF THE TUBE AFTER EACH REPOSITIONING." THE REPORTED COMPLAINT OF "LEAK - BALLOON CUFF" COULD NOT BE CONFIRMED SINCE THE ACTUAL SAMPLE WAS NOT RETURNED. THE CUSTOMER RETURNED A REPRESENTATIVE SAMPLE IN PLACE OF THE ACTUAL SAMPLE THAT RESULTED IN THE COMPLAINT ISSUE. UPON FUNCTIONAL INSPECTION, NO PROBLEMS WERE FOUND WITH THE RETURNED DEVICE AS IT WAS ABLE TO PROPERLY INFLATE AND DEFLATE. NO LEAKS WERE FOUND WITH THE SAMPLE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE DEVICE WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THE PROBABLE CAUSE OF THIS COMPLAINT ISSUE COULD NOT BE DETERMINED WITHOUT THE ACTUAL DEVICE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED "PRODUCT TEST BEFORE USE, AIRBAG FAILURE CAN NOT BE INFLATED, CAN NOT BE USED NORMALLY." THERE WAS NO PATIENT INVOLVEMENT. NO PATIENT HARM OR INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED "PRODUCT TEST BEFORE USE, AIRBAG FAILURE CAN NOT BE INFLATED, CAN NOT BE USED NORMALLY." THERE WAS NO PATIENT INVOLVEMENT. NO PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268266 ET TUBE, SHER-I-BRONCH, LS, 37 FR TUBE, TRACHEAL/BRONCHIAL, DIFF CBI TELEFLEX MEDICAL 73M1900384

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NONE REPORTED| NONE REPORTED