BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE CUFFED TRACHEOSTOMY T

    MDR report key: 148020 · Received February 3, 1998

    Report

    Report Number
    2029387-1997-00206
    Event Type
    Malfunction
    Date Received
    February 3, 1998
    Date of Event
    November 1, 1997
    Report Date
    December 6, 1997
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONE (1) 4 DCT OUTER CANNULA; ONE (1) 6 DCT OUTER CANNULA AND ONE (1) 8 CFN DEVICES WERE RETURNED TO THE MFR FOR IDENTIFICATION, ANALYSIS AND INVESTIGATION ON 12/18/1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA LOW PRESSURE CUFFED TRACHEOSTOMY T Implant TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL, INC. 4DCT; 6DCT; 8CFN M621258000; UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR