BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE CANNULA LOW PRESSURE CUFFED TRACHEOSTOMY TUBE

    MDR report key: 18870 · Received January 9, 1995

    Report

    Report Number
    MW1004693
    Event Type
    Malfunction
    Date Received
    January 9, 1995
    Date of Event
    January 4, 1995
    Report Date
    January 4, 1995
    Manufacturer
    MALLINCKRODT MEDICAL TPI, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT IN PROCESS OF TRACHEOSTOMY PLACEMENT. UNABLE TO SIT INNER CANNULA PROPERLY. CUFF AND CANNULA REMOVED AND A NEW CUFF AND CANNULA INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE CANNULA LOW PRESSURE CUFFED TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL TPI, INC. 9399113800

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other