BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINOUS EPIDURAL TRAY

    MDR report key: 106257 · Received July 17, 1997

    Report

    Report Number
    1217052-1997-00031
    Event Type
    Malfunction
    Date Received
    July 17, 1997
    Date of Event
    June 1, 1997
    Report Date
    June 17, 1997
    Manufacturer
    SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CLINICIAN DREW SALINE INTO THE 5CC GLASS SYRINGE PREPARING TO PERFORM THE LOSS OF RESISTANCE TECHNIQUE. PRIOR TO USING THE SYRINGE, THE CLINICIAN ALLEGEDLY NOTICED A PIECE OF FOREIGN MATTER FLOATING IN THE SYRINGE FLUID. THE SYRINGE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINOUS EPIDURAL TRAY KIT, CONDUCTION, ANESTHETIC CAZ SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. NA 704210

    Patients

    Seq Age Sex Outcome Treatment
    1 *