BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY SPECIALIZED SINGLE CANNULA CUFFED TRACHEOSTOMY TUBE

    MDR report key: 148310 · Received February 5, 1998

    Report

    Report Number
    2029387-1997-00203
    Event Type
    Malfunction
    Date Received
    February 5, 1998
    Date of Event
    November 7, 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
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INFLATION COULD NOT BE MAINTAINED ON ONE (1), M6.5 SCT, SPECIALIZED SINGLE CANNULA CUFFED TRACHEOSTOMY TUBES. THE DEVICE WAS IS USE APPROX TWO (2) WEEKS WHEN THE INFLATION PROBLEM OCCURRED. IT WAS ALSO REPORTED THAT THE DEVICE WAS TESTED PRIOR TO INSERTION WHERE NO INFLATION PROBLEMS WERE NOTED. THERE WAS ONE (1) PT INVOLVED WITH NO REPORTED PT COMPROMISE. THE M6.5 SCT DEVICE WAS RETURNED TO THE MFR FOR DECONTAMINATION, ANALYSIS AND INVESTIGATION ON 11/15/97. DEVICE EVALUATION RESULTS ARE RECORDED ON SECTION H. OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY SPECIALIZED SINGLE CANNULA CUFFED TRACHEOSTOMY TUBE Implant TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL, INC. M6.5SCT M73738000

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR CONNECTORS/ADAPTORS (MFR MODEL TYPE UNK).| PLV VENTILATOR (MODEL TYPE UNK), VARIOUS