BEUDAMED
    FDA Adverse Event Death Summary report: N

    MALLINCKRODT

    MDR report key: 8128498 · Received November 14, 2018

    Report

    Report Number
    8020889-2018-00134
    Event Type
    Death
    Date Received
    November 14, 2018
    Date of Event
    November 7, 2018
    Report Date
    November 7, 2018
    Manufacturer
    MALLINCKRODT MEDICAL
    Product Code
    BSK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE TUBE DISCONNECTED FROM THE PATIENT DUE TO SEPARATION OF THE TUBE CONNECTOR FROM THE ACTUAL TUBE IN THE PATIENT'S THROAT. THE CUSTOMER REPORTED THAT THE PATIENT HAD CONNECTOR DISCONNECTED FROM THE TUBE A FEW TIMES DURING THE SHIFT. THAT PATIENT WAS EXTUBATED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE ET TUBE DISCONNECTED FROM PATIENT DUE TO SEPARATION OF THE ET TUBE CONNECTOR FROM THE ACTUAL TUBE IN PATIENT'S THROAT. THE CUSTOMER REPORTED THAT PATIENT HAD CONNECTOR DISCONNECT FROM THE TUBE A FEW TIMES DURING THE SHIFT. PATIENT DEATH WAS NOT RELATED TO THE DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907840 MALLINCKRODT BSK MALLINCKRODT MEDICAL 109-70

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death