BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX EPIDURAL CUSTOM CONTINUOUS TRAY

    MDR report key: 8724021 · Received June 21, 2019

    Report

    Report Number
    3012307300-2019-02720
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Date of Event
    August 1, 2018
    Report Date
    June 21, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    POSSIBLE LOT: 180426. REPORT SOURCE: FOREIGN (B)(6). DEVICE EVALUATION: ONE FLAT FILTER AND EPIFUSE CONNECTOR WERE RETURNED FOR INVESTIGATION. WHEN EXAMINING THE PRODUCT, IT WAS CONFIRMED THAT THE BASE OF THE MALE CONNECTOR OF THE FLAT FILTER WAS BROKEN AND THE FRACTURED SURFACE WAS WHITENED. THE WHITENING WAS SEEN WHEN THE PLASTIC MATERIAL BROKE DUE TO EXTERNAL LOAD WAS CONFIRMED IN THE FILTER. THEREFORE, IT IS POSSIBLE THAT THE SAMPLE WAS BROKEN BY AN EXCESSIVE LOAD ON A CONTINUOUS OR INSTANTANEOUS BASIS. BASED ON THE INVESTIGATION, THE COMPLAINT ALLEGATION WAS CONFIRMED. IT WAS ALSO NOTED THERE WAS A HIGH PROBABLY OF DAMAGE DUE TO THE LOAD DURING USE OF THE PRODUCT. THEREFORE, USER INTERFACE WAS STATED AS THE PROBLEM SOURCE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT THE EPIDURAL ANESTHESIA FILTER AND EPIFUSE CONNECTOR FROM A SMITHS MEDICAL PORTEX EPIDURAL CUSTOM CONTINUOUS TRAY WERE LAID UNDER A PATIENT'S BODY DURING USE. DUE TO THE POSITIONING, IT WAS REPORTED THE CONNECTION BENT AND CAUSED MEDICAL FLUID TO LEAK FROM IT. THE PATIENT REPORTED TO HAVE COMPLAINED OF PAIN, BUT NO BLEEDING WAS REPORTED. THE FILTER AND CONNECTOR WERE REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515861 PORTEX EPIDURAL CUSTOM CONTINUOUS TRAY ANESTHESIA CONDUCTION KIT CAZ SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1