BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY TRACHEOSTOMY TUBE

    MDR report key: 133340 · Received November 10, 1997

    Report

    Report Number
    MW1012482
    Event Type
    Malfunction
    Date Received
    November 10, 1997
    Date of Event
    October 10, 1997
    Report Date
    October 21, 1997
    Manufacturer
    MALLINCKRODT MEDICAL TPI, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NOT ABLE TO INSERT DISPOSABLE INNER CANNULA IN #6 SHILEY TRACHEOSTOMY TUBE. INDENTATION ON REAR WALL OF TRACHEOSTOMY TUBE ALONG WITH 2 "CASE PLUGS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY TRACHEOSTOMY TUBE DISPOSABLE CANNULA-SIZE 6 BTO MALLINCKRODT MEDICAL TPI, INC. * M74345000

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other