BEUDAMED
    FDA Adverse Event Death Summary report: N

    HUDSON SHERIDAN

    MDR report key: 7496117 · Received May 8, 2018

    Report

    Report Number
    3003898360-2018-00354
    Event Type
    Death
    Date Received
    May 8, 2018
    Date of Event
    May 1, 2017
    Report Date
    April 17, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SINCE THE PART NUMBER WAS NOT PROVIDED AND THE ACTUAL SAMPLE WAS NOT RETURNED, 200 SAMPLES FROM THE ET TUBE FAMILY WERE TAKEN FROM CURRENT PRODUCTION AT THE MANUFACTURING FACILITY FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND NO ISSUES WERE DETECTED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). TELEFLEX RECEIVED THIS NOTIFICATION VIA MED WATCH ON 17 APRIL 2018. USER FACILITY SUBMITTED THE REPORT AS A MALFUNCTION AND DEATH. TELEFLEX REQUESTED ON 18 APRIL 2018 A STATEMENT FROM A MEDICAL PROFESSIONAL, AT THE USER FACILITY, AS TO WHETHER THE ALLEGED ISSUE WITH THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH. THE CUSTOMER'S RESPONSE WAS "THE DOCTOR COULD NOT MAKE AN ABSOLUTE DETERMINATION BECAUSE IT HAPPENED SO LONG BEFORE WE [USER FACILITY] REPORTED IT". TELEFLEX IS REPORTING THE EVENT AS A MALFUNCTION AND DEATH HOWEVER IT IS NOT CLEAR THAT THE ALLEGED MALFUNCTION DIRECTLY CAUSED OR CONTRIBUTED TO THE PATIENT OUTCOME. TELEFLEX CONTACTED THE CUSTOMER FOR ADDITIONAL INFORMATION, ALSO ON 18 APRIL 2018. AT THIS TIME TELEFLEX REQUESTED THE CATALOG NUMBER AND LOT NUMBER OF DEVICE INVOLVED, AS WELL AS THE DEVICE SAMPLE FOR INVESTIGATION. CUSTOMER RESPONDED "THE INCIDENT HAPPENED IN (B)(6) 2017, BUT WE [USER FACILITY] WERE ALERTED ABOUT IT IN OCTOBER 2017. SO WE [USER FACILITY] DIDN'T HAVE A CHANCE TO COLLECT AND SEQUESTER THE ITEM." DEATH DATE REPORTED VIA MEDWATCH AS "__ (B)(6) 2017". THE INVESTIGATION INTO THIS COMPLAINT IS STILL IN PROGRESS AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "THE PATIENT WAS INTUBATED IN ICU FOR RESPIRATORY FAILURE. THE ENDOTRACHEAL TUBE WAS NOTED TO HAVE AN ISSUE WITH THE ADAPTER COMING LOOSE AT THE END OF THE ETT. THE DECISION WAS MADE TO EXCHANGE THE ETT. DURING THE EXCHANGE, THE PATIENT HAD A RESPIRATORY/CARDIAC ARREST. THE PATIENT WAS REVIVED, HOWEVER, EXPIRED THE NEXT DAY."

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "THE PATIENT WAS INTUBATED IN ICU FOR RESPIRATORY FAILURE. THE ENDOTRACHEAL TUBE WAS NOTED TO HAVE AN ISSUE WITH THE ADAPTER COMING LOOSE AT THE END OF THE ETT. THE DECISION WAS MADE TO EXCHANGE THE ETT. DURING THE EXCHANGE, THE PATIENT HAD A RESPIRATORY/CARDIAC ARREST. THE PATIENT WAS REVIVED, HOWEVER, EXPIRED THE NEXT DAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338573 HUDSON SHERIDAN TUBE, TRACHEAL (W/WO CONNECTOR) BTR TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| R