BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ET TUBE, SHER-I-BRONCH, LS, 35 FR

    MDR report key: 11065280 · Received December 23, 2020

    Report

    Report Number
    3003898360-2020-01109
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Date of Event
    December 3, 2020
    Report Date
    December 9, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CBI
    PMA / PMN Number
    K180253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE CUSTOMER RETURNED ONE UNIT 5-16035 ET TUBE, SHER-I-BRONCH, LS, 35 FR FOR INVESTIGATION. THE ET TUBE WAS VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE SAMPLE APPEARS TYPICAL. FUNCTIONAL INSPECTION WAS PERFORMED TO ATTEMPT TO INFLATE AND DEFLATE THE CUFFS ON THE RETURNED SAMPLE. A LAB INVENTORY SYRINGE WAS FILLED WITH AIR. THEN THE SYRINGE WAS CONNECTED TO THE BRONCHIAL (BLUE) PILOT BALLOON. USING HAND PRESSURE, AIR WAS INJECTED THROUGH THE VALVE. UPON INJECTION OF AIR, THE BRONCHIAL BALLOON CUFF WAS ABLE TO PROPERLY INFLATE. THE SYRINGE WAS THEN ATTACHED TO THE TRACHEAL (WHITE) PILOT BALLOON. UPON INJECTION OF AIR, THE TRACHEAL BALLOON CUFF WAS UNABLE TO STAY INFLATED. BOTH BALLOON CUFFS WERE FULLY DEFLATED WITH NO ISSUES. THE ET TUBE WAS SUBMERGED UNDER WATER AND AN ATTEMPT TO INFLATE WAS MADE TO DETECT ANY ADDITIONAL LEAKS. UPON INJECTION, THE ET TUBE LEAKED FROM A HOLE IN THE TRACHEAL BALLOON CUFF. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED. THE IFU FOR THIS PRODUCT STATES, "THE ENDOBRONCHIAL CUFFS SHOULD BE SLOWLY INFLATED WITH THE MINIMUM AMOUNT OF AIR REQUIRED TO PROVIDE AN EFFECTIVE SEAL. DO NOT INFLATE WITH A MEASURED VOLUME OR A FEEL OF PRESSURE IN THE SYRINGE SINCE LITTLE RESISTANCE SHOULD BE FELT DURING INFLATION." "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." "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." THE REPORTED COMPLAINT WAS CONFIRMED BASED UPON THE SAMPLE RECEIVED. THE RETURNED ET TUBE WAS FOUND TO HAVE A HOLE IN THE TRACHEAL BALLOON CUFF WHICH PREVENTED IT FROM BEING ABLE TO STAY INFLATED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. ALL ET TUBES ARE 100% INSPECTED FOR INFLATION AND DEFLATION AT THE TIME OF MANUFACTURING. IT IS UNLIKELY THAT THIS TYPE OF DAMAGE WAS PRESENT AT THE TIME OF MANUFACTURING. THEREFORE, BASED UPON THE DAMAGE OBSERVED, UNINTENTIONAL USER ERROR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE DURING CLINICAL INSPECTION BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A VERIFICATION OF THE REPORTED FAILURE MODE WAS CONDUCTED, AND 80 SAMPLES WERE TAKEN FROM THE CURRENT PRODUCTION (5-16035 ET TUBE, SHER-I-BRONCH, LS, 35 FR. LOT # 2972623) AT THE MANUFACTURING FACILITY. THE SAMPLES WERE VISUALLY INSPECTED, AND ISSUE REPORTED "LEAK - BALLOON CUFF" WAS NOT OBSERVED 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. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE DURING CLINICAL INSPECTION BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1531435 HUDSON ET TUBE, SHER-I-BRONCH, LS, 35 FR TUBE, TRACHEAL/BRONCHIAL, DIFF CBI TELEFLEX MEDICAL 73D1900180

    Patients

    Seq Age Sex Outcome Treatment
    1