BEUDAMED
    FDA Adverse Event Death Summary report: N

    HUDSON ET TUBE, CF MAG, 7.0

    MDR report key: 5101323 · Received September 24, 2015

    Report

    Report Number
    3003898360-2015-00662
    Event Type
    Death
    Date Received
    September 24, 2015
    Date of Event
    February 20, 2015
    Report Date
    September 2, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. CORRECTIVE ACTIONS CANNOT BE ESTABLISHED SINCE IT IS NECESSARY TO RECEIVE THE DEVICE SAMPLE TO PERFORM A PROPER INVESTIGATION AND CONFIRM THE ALLEGED DEFECT. AT THIS TIME SINCE THE SAMPLE IS NOT AVAILABLE IT IS NOT POSSIBLE TO DETERMINE THE SOURCE OF THE DEFECT REPORTED. CUSTOMER COMPLAINT CANNOT BE CONFIRMED SINCE THE DEVICE SAMPLE IS NOT AVAILABLE TO PERFORM A PROPER INVESTIGATION AND DETERMINE THE ROOT CAUSE. IF THE DEVICE SAMPLE BECOMES AVAILABLE AT A LATER DATE, THIS COMPLAINT WILL BE UPDATED ACCORDINGLY. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE CUFF OF THE ENDOTRACHEAL TUBE LEAKED. THE ENDOTRACHEAL TUBE WAS CHANGED AND NO COMPLICATIONS OR ASPIRATION NOTED. POST SURGERY, THE PATIENT SPENT 6 DAYS IN INTENSIVE CARE REQUIRING MECHANICAL VENTILATION AND CARDIOVASCULAR SUPPORT. A REPEAT CT SCAN WAS DONE AND REVEALED COLLECTION OF PUS. THE COLLECTION OF PUS WAS DRAINED, BUT THE FOLLOWING DAY THE PATIENT'S CONDITION DETERIORATED LEADING TO FURTHER EMERGENCY SURGERY AND SHORTLY AFTER THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631039 HUDSON ET TUBE, CF MAG, 7.0 ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death