BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY CUFFLESS TRACHEOSTOMY TUBE

    MDR report key: 184979 · Received January 26, 1998

    Report

    Report Number
    2029387-1997-00153
    Event Type
    Malfunction
    Date Received
    January 26, 1998
    Date of Event
    July 8, 1997
    Report Date
    December 29, 1997
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHORTLY AFTER INTUBATING A SIZE 6 CFS, CUFFLESS TRACHEOSTOMY TUBE, PATIENT EXPERIENCED DISCOMFORT AND TRACHEAL BLEEDING. THE DEVICE WAS REMOVED APPROXIMATELY TWENTY-FOUR HOURS AFTER INSERTION AND REPLACED WITH A SECOND 6 CFS DEVICE WITH NO FURTHER PROBLEMS REPORTED. VISUAL EXAMINATION PRIOR TO AND AFTER REMOVAL OF THE 6 CFS DEVICE DID NOT REVEAL ANY OBVIOUS ABNORMALITIES. THERE WAS ONE PATIENT INVOLVED WITH NO REPORTED PATIENT COMPROMISE. THE 6 CFS DEVICE WAS RETURNED TO THE MANUFACTURER FOR IDENTIFICATION, DECONTAMINATION, ANALYSIS AND INVESTIGATION ON 09/08/1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY CUFFLESS TRACHEOSTOMY TUBE Implant TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL, INC. 6CFS M64322000

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR