BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11950712 · Received June 7, 2021

    Report

    Report Number
    3003898360-2021-00512
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    April 22, 2021
    Report Date
    May 17, 2021
    Product Code
    CBI
    UDI-DI
    14026704617446
    PMA / PMN Number
    K180253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. A VERIFICATION OF THE REPORTED FAILURE MODE WAS CONDUCTED, AND 52 SAMPLES WERE TAKEN FROM THE CURRENT PRODUCTION (MATERIAL NUMBER 00196-35 LOT # 3052033) AT THE MANUFACTURING FACILITY. THE SAMPLES WERE VISUALLY INSPECTED, AND ISSUE REPORTED "LEAK - BALLOON CUFF" WAS NOT OBSERVED IN THE CURRENT MANUFACTURING PROCESS. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE DOCTOR FOUND THAT THE CUFF WAS LEAKAGE WHEN USING ON PATIENT. THEN CHANGED NEW ONE, NO IMPACT ON PATIENT". PATIENT CONDITION REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846539 HUDSON ET TUBE, SHER-I-BRONCH, RS, 35 FR TUBE, TRACHEAL/BRONCHIAL, DIFF CBI IPN049000 73D1900617 14026704617446

    Patients

    Seq Age Sex Outcome Treatment
    1