BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETT

    MDR report key: 11697364 · Received April 20, 2021

    Report

    Report Number
    3003898360-2021-00387
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    March 16, 2021
    Report Date
    March 26, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    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 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 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 "THERE WAS A CONFIRMED PINHOLE LEAK AROUND THE CUFF. THE PATIENT HAD AN ENDOTRACHEAL TUBE EXCHANGE WITH THE ENTIRE INCIDENT RESULTING IN MINIMAL DESATURATION AND NO PATIENT COMPLICATIONS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590169 ETT TUBE, TRACHEAL (W/WO CONNECTOR BTR TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1