BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERI-CATH

    MDR report key: 107955 · Received July 25, 1997

    Report

    Report Number
    1217052-1997-00034
    Event Type
    Malfunction
    Date Received
    July 25, 1997
    Date of Event
    June 23, 1997
    Report Date
    June 26, 1997
    Manufacturer
    SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
    Product Code
    BSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    THE CLINICIAN REPORTS THAT HE WENT TO CHANGE THE STERI-CATH AFTER 48 HOURS USE. WHILE DISCONNECTING THE SUCTION TUBING FROM THE CATHETER, THE CLINICIAN ALLEGES THAT THE CATHETER BROKE AND HE CUT HIS FINGER ON THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERI-CATH CATHETER, SUCTION, TRACHEOBRONCHIAL BSY SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. NA POSSIBLE LOT 703291,703293

    Patients

    Seq Age Sex Outcome Treatment
    1 * SUCTION TUBING