BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERI-CATH

    MDR report key: 93903 · Received May 28, 1997

    Report

    Report Number
    1217052-1997-00023
    Event Type
    Malfunction
    Date Received
    May 28, 1997
    Date of Event
    April 1, 1997
    Report Date
    April 28, 1997
    Manufacturer
    SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
    Product Code
    BSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HOSPITAL ALLEGES THAT THE STERI-CATH WAS ATTACHED TO THE PT'S ENDOTRACHEAL TUBE WHEN THE VENTILATOR ALARM SOUNDED. THE CATHETER WAS REMOVED AND LATER REPLACED WITH ANOTHER AND THERE WAS NO PT INJURY. THE HOSPITAL ESTIMATES BASED ON THE VENTILATOR ALARM SETTINGS, THAT 150-200CC'S OF TIDAL VOLUME WAS LEAKING PAST THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERI-CATH CATHETER, SUCTION, TRACHEOBRONCHIAL BSY SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. NA 703155 (POSSIBLE LOT #)

    Patients

    Seq Age Sex Outcome Treatment
    1 * ENDOTRACHEAL TUBE AND VENTILATOR