BEUDAMED
    FDA Adverse Event Death Summary report: N

    ET TUBE W/ STYLET, CUFFED SIZE 8

    MDR report key: 5833025 · Received July 29, 2016

    Report

    Report Number
    8030673-2016-00196
    Event Type
    Death
    Date Received
    July 29, 2016
    Date of Event
    July 8, 2016
    Report Date
    October 21, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    BTR
    PMA / PMN Number
    K042683
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - INITIAL EMDR SUBMISSION. THE SAMPLE HAS BEEN REQUESTED FROM THE CUSTOMER. AT THIS TIME WE ARE AWAITING FOR THE SAMPLE TO BE RETURNED FROM THE CUSTOMER. THE CUSTOMER STATED THAT THE DEVICE MALFUNCTION DID NOT CONTRIBUTE TO THE PATIENT'S DEATH. THE PATIENT HAS EXPIRED FROM OTHER CO MORBIDITIES. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL SUBMISSION WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS FOR COMPLAINT NUMBER (B)(4). AN OPENED SAMPLE WAS RECEIVED FOR EVALUATION. DURING THE VISUAL INSPECTION, IT WAS OBSERVED THAT THE CUFF WHICH IS BY THE BEVEL OF THE END OF THE ENDOTRACHEAL TUBE WAS NOT DEFECTIVE. HOWEVER, THE PILOT LINE WHICH INFLATES THE CUFF WAS FOUND TO BE BROKEN WHERE THE LINE ENTERS THE ENDOTRACHEAL TUBE. THE CUSTOMER¿S REPORTED FAILURE WAS CONFIRMED. THE CUSTOMER REPORTED LOT NUMBER DOES NOT CORRESPOND TO THE CAREFUSION PLANT, SO A REVIEW THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. TWO YEARS OF COMPLAINTS WERE REVIEWED AND NO TREND WAS DETECTED FOR THIS PRODUCT OR ISSUE. THE FAILED COMPONENT IS SUPPLIED TO CAREFUSION FROM WELL LEAD MEDICAL. WELL LEAD MEDICAL HAS BEEN NOTIFIED OF THIS ISSUE VIA A SCAR FROM CAREFUSION AND HAS BEEN REQUESTED TO DETERMINE THE ROOT CAUSE AND ACTION PLAN NEEDED TO CORRECT AND PREVENT THIS ISSUE FROM OCCURRING.

    Description of Event or Problem · 1

    "DEFECTIVE 8.0 CUFF. CUFF DID NOT INFLATE DUE TO TEAR. THE TREATMENT PROVIDED, WAS RE-INTUBATION. CLINICAL STATUS OF THE PATIENT AT THIS TIME IS EXPIRED. THE PATIENT EXPIRED ON (B)(6) 2016, AND THE PRODUCT FAILURE WAS NOT RELATED TO PATIENT'S DEATH, IT WAS DUE TO OTHER COMPLICATIONS (CO MORBIDITIES)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485427 ET TUBE W/ STYLET, CUFFED SIZE 8 TUBE, TRACHEAL (W/WO CONNECTOR) BTR CAREFUSION, INC 1506020868

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death| R