BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ET TUBE, HVT, 7.0

    MDR report key: 11679714 · Received April 16, 2021

    Report

    Report Number
    3003898360-2021-00376
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    March 16, 2021
    Report Date
    March 26, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    UDI-DI
    14026704616746
    PMA / PMN Number
    K822082
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 THE REPORTED FAILURE MODE WAS CONDUCTED, AND 400 SAMPLES WERE TAKEN FROM THE CURRENT PRODUCTION (MATERIAL NUMBER 00003-14 LOT # 3027607) AT THE MANUFACTURING FACILITY. THE SAMPLES WERE VISUALLY INSPECTED, AND ISSUE REPORTED "LEAK - DEVICE LEAK - 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 "CUSTOMER HAD A COMPLAINT REGARDING ETT CONNECTOR ISSUES AND LEAKAGE AROUND THE CUFF DURING USE ON A PATIENT". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION UNKNOWN AT TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576563 HUDSON ET TUBE, HVT, 7.0 TUBE, TRACHEAL (W/WO CONNECTOR BTR TELEFLEX MEDICAL IPN048895 UNKNOWN 14026704616746

    Patients

    Seq Age Sex Outcome Treatment
    1