BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 42437 · Received October 8, 1996

    Report

    Report Number
    42437
    Event Type
    Injury
    Date Received
    October 8, 1996
    Date of Event
    September 10, 1996
    Report Date
    October 1, 1996
    Manufacturer
    MALLINCKRODT MEDICAL TPI, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    WHEN THERAPIST WENT TO CHANGE PT BACK TO VENT, NOTICED WHAT APPEARED TO BE A 2ND INNER CANNULA INSIDE THE DISPOSABLE INNER CANNULA. UPON CLOSER EXAMINATION, THE CANNULA HAD SEPARATED ITSELF FROM THE CLIPS AND WAS PROTRUDING OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY #8 DISPOSABLE TRACH BTO MALLINCKRODT MEDICAL TPI, INC. #8 D/C M62895000

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention