BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERI-CATH

    MDR report key: 101061 · Received June 27, 1997

    Report

    Report Number
    1217052-1997-00030
    Event Type
    Injury
    Date Received
    June 27, 1997
    Date of Event
    May 24, 1997
    Report Date
    May 29, 1997
    Manufacturer
    SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
    Product Code
    BSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER CHANGING THE STERI-CATH ON A MECHANICALLY VENTILATED PT, THE CLINICIAN ALLEGEDLY NOTED THAT THE PT'S EXHALED TIDAL VOLUME WAS ONLY 280-300 ML AND THE TIDAL VOLUME WAS SET AT 600ML. THE PT HAD AN SA02 OF 80%. THE PT WAS TAKEN OFF THE VENTILATOR AND MANUALLY VENTILATED WHILE THE VENTILATOR AND CIRCUIT WERE CHECKED. THE CLINICIAN REPORTEDLY DISCOVERED THAT THE STERI-CATH THUMB VALVE WAS NOT WORKING PROPERLY ALLEDGELY ALLOWING THE TIDAL VOLUME LOSS. THE STERI-CATH WAS REPLACED AND THE PT'S TIDAL VOLUME AND SA02 RETURNED TO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERI-CATH CATHETER, SUCTION, TRACHEOBRONCHIAL BSY SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. NA 610359

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention ENDOTRACHEAL TUBE AND VENTRILATOR