BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ET TUBE, HVT, 7.5

    MDR report key: 12521064 · Received September 23, 2021

    Report

    Report Number
    3003898360-2021-00863
    Event Type
    Malfunction
    Date Received
    September 23, 2021
    Date of Event
    August 31, 2021
    Report Date
    August 31, 2021
    Product Code
    BTR
    UDI-DI
    14026704616753
    PMA / PMN Number
    K822082
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    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 FAILURE MODE REPORTED IN THE CURRENT MANUFACTURING PROCESS WAS CONDUCTED AS FOLLOWS: 895 SAMPLES WERE TAKEN FROM THE CURRENT PRODUCTION (MATERIAL # 00003-14 LOT # 3114465), THE CUFF FROM THE SAMPLES WERE INFLATED AND LEFT FOR FOUR HOURS, AFTER THIS TIME SAMPLES WERE CHECKED TO VERIFY IF ANY LEAK WAS PRESENT HOWEVER ALL SAMPLES WERE STILL FULLY INFLATED, DEFECT REPORTED "DOES NOT STAY INFLATED - CUFF" WAS NOT OBSERVED IN THE CURRENT MANUFACTURING PROCESS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED "THE ETT'S WOULD STOP HOLDING AIR. 7.5 HVT HAD TO BE REPLACED AFTER 4-5 DAYS". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION UNKNOWN AT TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1417641 HUDSON ET TUBE, HVT, 7.5 TUBE, TRACHEAL (W/WO CONNECTOR BTR IPN048896 73F2000554 14026704616753

    Patients

    Seq Age Sex Outcome Treatment
    1