BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUDSON ET TUBE,CF,6.5

    MDR report key: 12800274 · Received November 11, 2021

    Report

    Report Number
    3003898360-2021-01009
    Event Type
    Injury
    Date Received
    November 11, 2021
    Date of Event
    September 3, 2021
    Report Date
    October 20, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    UDI-DI
    14026704616500
    PMA / PMN Number
    K822082
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. PART NUMBER REPORTED, 5-10113 ET TUBE,CF,6.5, IS NOT BEING MANUFACTURED CURRENTLY, HOWEVER, ANOTHER PART NUMBER FROM THE SAME FAMILY (PART # 00001-08 LOT # 3150326) WAS USED FOR THE "VERIFICATION OF FAILURE MODE REPORTED IN THE CURRENT MANUFACTURING PROCESS" AND WAS CONDUCTED AS FOLLOWS: 125 SAMPLES WERE TAKEN FROM THE CURRENT PRODUCTION; THE SAMPLES WERE VISUALLY INSPECTED AND ISSUE REPORTED "LEAK - GAS LEAK - OTHER" 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 · 0

    IT WAS REPORTED THAT: "INCIDENT HAPPENED ON (B)(6) 2021, IN THE ORTHOPEDIC AND TRAUMA SURGERY UNIT. WE FACED LEAKS OF THE CUFF. THE CONSEQUENCE WAS A DESATURATION OF THE PATIENT WITH THE RISK OF ACUTE RESPIRATORY DISTRESS. THIS INCIDENT NECESSITATED AN OVERPRESSURE AT THE LEVEL OF THE CUFF". PATIENT CONDITION REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1695381 HUDSON ET TUBE,CF,6.5 TUBE, TRACHEAL (W/WO CONNECTOR BTR TELEFLEX MEDICAL IPN044729 73G1800793 14026704616500

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H| L