BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY DISPOSABLE INNER CANNULA & DISPOSABLE CANNULA LOW PRE

    MDR report key: 141732 · Received January 6, 1998

    Report

    Report Number
    2029387-1997-00181
    Event Type
    Malfunction
    Date Received
    January 6, 1998
    Date of Event
    August 1, 1997
    Report Date
    October 27, 1997
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FOUR (4) SIZE 6 DCT DEVICES AND TWENTY (20) SIZE 6 DIC COMPONENTS WERE RECEIVED 12/22/1997 BY THE MANUFACTURER. DEVICE EVALUATION RESULTS ARE RECORDED ON SECTION H OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE INNER CANNULA & DISPOSABLE CANNULA LOW PRE TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL, INC. 6 DIC & 6 DCT MULTIPLE (H.10)

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR PORTEX SWIVEL ADAPTOR| PURITAN BENNETT 2801 VENTILATOR