BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERI-CATH

    MDR report key: 91379 · Received May 16, 1997

    Report

    Report Number
    1217052-1997-00021
    Event Type
    Malfunction
    Date Received
    May 16, 1997
    Date of Event
    March 31, 1997
    Report Date
    April 18, 1997
    Manufacturer
    SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
    Product Code
    BSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE HOSP ALLEGES TWO EVENTS WHERE THE STERI-CATH WAS ATTACHED TO THE PT'S TRACHEOSTOMY OR ENDOTRACHEAL TUBE. WITHIN MINUTES OF ATTACHING THE CATHETER, THE HOSP STAFF NOTICED A DECREASE IN PT VENTILATION. THE STAFF CHANGED THE VENTILATOR WHICH DID NOT RESULT IN ANY IMPROVEMENT. THE STAFF CHANGED THE CATHETER AND THE DESIRED VENTILATION LEVEL WAS ATTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERI-CATH CATHETER, SUCTION, TRACHEOBRINCHIAL BSY SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. NA 609398

    Patients

    Seq Age Sex Outcome Treatment
    1 * TRACHEOSTOMY OR ENDOTRACHEAL TUBE. 2. VENTILATOR