BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIC TRACHEOSTOMY TUBE

    MDR report key: 234683 · Received August 5, 1999

    Report

    Report Number
    1217052-1999-00033
    Event Type
    Malfunction
    Date Received
    August 5, 1999
    Date of Event
    July 1, 1999
    Report Date
    July 6, 1999
    Manufacturer
    SIMS PORTEX, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TRACHEOSTOMY TUBE WAS IN USE WITH A CONTRACTED PATIENT. AFTER APPROIMATELY ONE WEEKS USE THE VENTILATOR ALARMS SOUNDED INDICATING A LEAK IN THE SYSTEM. A CLINICIAN NOTED THAT THE LEAK WAS ALLEGEDLY DUE TO A CRACK AT THE BASE OF THE TRACHEOSTOMY TUBE 15MM CONNECTOR. THERE WAS NO PATIENT COMPROMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIC TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE AND TUBE CUFF BTO SIMS PORTEX, INC. NA 811908

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO VENTILATOR, VENTILATOR CIRCUIT (7/1999 TO 7/1999).