BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUDSON ET TUBE, HVT, 8.0

    MDR report key: 12844984 · Received November 19, 2021

    Report

    Report Number
    3003898360-2021-01031
    Event Type
    Injury
    Date Received
    November 19, 2021
    Date of Event
    October 27, 2021
    Report Date
    October 27, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    UDI-DI
    14026704616746
    PMA / PMN Number
    K822082
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED A SIZE 8 ET TUBE FOR INVESTIGATION. UPON VISUAL EXAM OF THE RETURNED SAMPLE, IT WAS DETERMINED THAT THIS WAS NOT A TELEFLEX PRODUCT. MULTIPLE ATTEMPTS WERE MADE TO FOLLOW UP ON THE RETURNED SAMPLE; HOWEVER, THE CUSTOMER HAS NOT RESPONDED. A SECOND FOLLOW UP REPORT WILL BE SUBMITTED IF ANY PERTINENT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    QN# (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. P/N 5-10314 ET TUBE, HVT, 7.0 IS NOT BEING MANUFACTURED CURRENTLY, HOWEVER, ANOTHER PART NUMBER FROM THE SAME FAMILY WAS USE FOR THE "VERIFICATION OF FAILURE MODE REPORTED IN THE CURRENT MANUFACTURING PROCESS" (P/N 00003-12 LOT # 3150288)AND WAS CONDUCTED AS FOLLOWS: 200 SAMPLES WERE TAKEN FROM THE CURRENT PRODUCTION; THE SAMPLES WERE VISUALLY INSPECTED AND ISSUE REPORTED "LEAK - INFO NOT PROVIDED" 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. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    IT WAS REPORTED "WE HAD A PATIENT THAT HAD AN ETT THAT NEEDED CHANGED OUT THIS MORNING DUE TO A CUFF LEAK AGAIN". IT WAS FURTHER REPORTED THAT THE PATIENT "ENCOUNTERED FURTHER RESPIRATORY DISTRESS, HAD TO BE EXTUBATED AND REINTUBATED. PATIENT DID DESATURATE FEQUENTLY [INTO THE 70S] UNTIL TUBE WAS REPLACED". PATIENT CONDITION UNKNOWN AS IT WAS REPORTED "THE PATIENT WAS TRANSFERRED FROM OUR UNIT".

    Description of Event or Problem · 0

    IT WAS REPORTED "WE HAD A PATIENT THAT HAD AN ETT THAT NEEDED CHANGED OUT THIS MORNING DUE TO A CUFF LEAK AGAIN". IT WAS FURTHER REPORTED THAT THE PATIENT "ENCOUNTERED FURTHER RESPIRATORY DISTRESS, HAD TO BE EXTUBATED AND REINTUBATED. PATIENT DID DESATURATE FREQUENTLY [INTO THE 70S] UNTIL TUBE WAS REPLACED". PATIENT CONDITION UNKNOWN AS IT WAS REPORTED "THE PATIENT WAS TRANSFERRED FROM OUR UNIT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1746000 HUDSON ET TUBE, HVT, 8.0 TUBE, TRACHEAL (W/WO CONNECTOR BTR TELEFLEX MEDICAL IPN048895 UNKNOWN 14026704616746

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R| L VENTILATOR| VENTILATOR