BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ET TUBE,HVT,7.5,NOVA PLUS

    MDR report key: 11667713 · Received April 14, 2021

    Report

    Report Number
    3003898360-2021-00340
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    March 19, 2021
    Report Date
    March 23, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    UDI-DI
    04026704588787
    PMA / PMN Number
    K822082
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    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 315 SAMPLES WERE TAKEN FROM THE CURRENT PRODUCTION (MATERIAL NUMBER 00003-14 LOT # 3024109) AT THE MANUFACTURING FACILITY. THE SAMPLES WERE VISUALLY INSPECTED, AND ISSUE REPORTED "LEAK - DEVICE LEAK - 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 "CRNA LEAD ((B)(6) CRNA) REPORTED 5 OF THE 7.5 ETT'S EXPERIENCING LEAKING CUFFS WHEN TESTING THEM PRIOR TO INSERTION INTO A PATIENT". NO PATIENT INVOLVEMENT REPORTED. IT WAS REPORTED THAT THE DEVICE WAS REPLACED BEFORE USE ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564245 HUDSON ET TUBE,HVT,7.5,NOVA PLUS TUBE, TRACHEAL (W/WO CONNECTOR BTR TELEFLEX MEDICAL IPN046759 73H2000272 04026704588787

    Patients

    Seq Age Sex Outcome Treatment
    1