BEUDAMED
    FDA Adverse Event Death Summary report: N

    HUDSON ET TUBE, HVT, 7.5

    MDR report key: 12520360 · Received September 23, 2021

    Report

    Report Number
    3003898360-2021-00878
    Event Type
    Death
    Date Received
    September 23, 2021
    Date of Event
    August 31, 2021
    Report Date
    August 31, 2021
    Product Code
    BTR
    UDI-DI
    14026704616753
    PMA / PMN Number
    K822082
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    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. P/N 5-10315 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" AND WAS CONDUCTED AS FOLLOWS: 590 SAMPLES WERE TAKEN FROM THE CURRENT PRODUCTION FROM P/N 00003-14 ASSEMBLY ,SHERIDAN HVT MURPHY TRACH,7.5MM LOT# 3118711 THE SAMPLES WERE VISUALLY INSPECTED AND ISSUE REPORTED "DOES NOT STAY INFLATED - CUFF" WAS NOT OBSERVED IN THE CURRENT MANUFACTURING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. 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. CORRECTED DATA: SECTION F.10.- MEDICAL DEVICE PROBLEM CODE CORRECTED TO 1149 SECTION H.6.- MEDICAL DEVICE PROBLEM CODE CORRECTED TO 1149.

    Description of Event or Problem · 0

    IT WAS REPORTED "ET TUBES ARE NOT HOLDING AIR - PATIENT STARTS DISTRESSING AND CLINICIAN USES A BOUGIE TO EXCHANGE ET TUBE". FURTHER INFORMATION PROVIDED STATES "CLINICIAN REPLACED 7.5 ETT WITH AN 8.0 ETT 1 DAY PRIOR TO THE PATIENT EXPIRING. [THE PATIENT] PROCEEDED TO CODE THEN EXPIRE". CUSTOMER UNABLE TO CONFIRM IF "CHANGING THE TUBE RESULTED IN THE [PATIENTS] DEATH THE FOLLOWING DAY".

    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. P/N 5-10315 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" AND WAS CONDUCTED AS FOLLOWS: 590 SAMPLES WERE TAKEN FROM THE CURRENT PRODUCTION FROM P/N 00003-14 ASSEMBLY, SHERIDAN HVT MURPHY TRACH,7.5MM LOT# 3118711 THE SAMPLES WERE VISUALLY INSPECTED AND ISSUE REPORTED "TORN/RUPTURED - CUFF" WAS NOT OBSERVED IN THE CURRENT MANUFACTURING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. 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 "ET TUBES ARE NOT HOLDING AIR - PATIENT STARTS DISTRESSING AND CLINICIAN USES A BOUGIE TO EXCHANGE ET TUBE". FURTHER INFORMATION PROVIDED STATES "CLINICIAN REPLACED 7.5 ETT WITH AN 8.0 ETT 1 DAY PRIOR TO THE PATIENT EXPIRING. [THE PATIENT] PROCEEDED TO CODE THEN EXPIRE". CUSTOMER UNABLE TO CONFIRM IF "CHANGING THE TUBE RESULTED IN THE [PATIENTS] DEATH THE FOLLOWING DAY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1416102 HUDSON ET TUBE, HVT, 7.5 TUBE, TRACHEAL (W/WO CONNECTOR BTR IPN048896 14026704616753

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L| R