BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    EVACUATED CONTAINER

    MDR report key: 8279960 · Received January 25, 2019

    Report

    Report Number
    1416980-2019-00271
    Event Type
    Malfunction
    Date Received
    January 25, 2019
    Report Date
    January 25, 2019
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT # - G133942, G134270, G134965, AND G134445. A BATCH REVIEW WAS CONDUCTED FOR LOT NUMBERS G133942, G134270, G134965, AND G134445, AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THESE LOTS. THE DEVICES WERE NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 4 </NOE> MALFUNCTION EVENTS. IT WAS REPORTED THAT PARTICULATE MATTER (PM) WAS OBSERVED WITHIN FOUR (4) 1000ML EVACUATED CONTAINERS. THE PM WAS FURTHER DESCRIBED AS "MINUTE GLASS PARTICLES". THIS WAS NOTED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69609 EVACUATED CONTAINER APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED GCY BAXTER HEALTHCARE - CLEVELAND NA SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1