BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ET TUBE, HVT, 8.0

    MDR report key: 12068081 · Received June 25, 2021

    Report

    Report Number
    3003898360-2021-00558
    Event Type
    Malfunction
    Date Received
    June 25, 2021
    Date of Event
    May 8, 2021
    Report Date
    June 4, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    UDI-DI
    14026704616760
    PMA / PMN Number
    K822082
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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. PART NUMBER REPORTED, 5-10316 ET TUBE, HVT, 8.0, IS NOT BEING MANUFACTURED CURRENTLY, HOWEVER, ANOTHER PART NUMBER FROM THE SAME FAMILY, MATERIAL NUMBER 00003-15 LOT NUMBER 3062687, WAS USED FOR THE "VERIFICATION OF FAILURE MODE REPORTED IN THE CURRENT MANUFACTURING PROCESS" AND WAS CONDUCTED AS FOLLOWS: 315 SAMPLES WERE TAKEN FROM THE CURRENT PRODUCTION, 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 "LEAK - DEVICE LEAK - CUFF" WAS NOT OBSERVED IN THE CURRENT MANUFACTURING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS NOT PERFORMED, AS THE LOT NUMBER WAS NOT PROVIDED AT TIME OF REPORT. 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 "WHEN THE TUBE HAS TO STAY IN THE PATIENT FOR A WHILE, THERE IS A CUFF LEAKAGE. CUFF HAS TO BE INFLATED OR REPLACED". NO PATIENT INJURY OR CONSEQUENCE REPORTED. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. PATIENT CONDITION UNKNOWN AT TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967777 HUDSON ET TUBE, HVT, 8.0 TUBE, TRACHEAL (W/WO CONNECTOR BTR TELEFLEX MEDICAL IPN048897 UNKNOWN 14026704616760

    Patients

    Seq Age Sex Outcome Treatment
    1