BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECOFLX 500 ML EMPTYING MIXTURE BAG

    MDR report key: 22776837 · Received August 11, 2025

    Report

    Report Number
    MW5174359
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    August 6, 2025
    Report Date
    August 6, 2025
    Manufacturer
    DOUGLAS MEDICAL PRODUCTS, INC.
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ECOFLX 500 ML EMPTYING MIXTURE CONTAINER (PVC-FREE) LOT(10): C24S0780, EXP (17): 10-2029 WE'VE OBSERVED THAT AFTER INJECTING INTO THE CONTAINER, PARTICULATE MATTER OR "FREE FLOATERS" APPEAR INSIDE THE BAG. THIS ISSUE HAS BEEN NOTED ACROSS MULTIPLE UNITS FROM THE SAME LOT. THE PARTICLES SEEM TO ORIGINATE POST-INJECTION, SUGGESTING A POSSIBLE INTERACTION WITH THE RUBBER STOPPER OR INTERNAL COMPONENTS OF THE CONTAINER. FURTHER INVESTIGATION MAY BE WARRANTED TO ASSESS PRODUCT INTEGRITY AND POTENTIAL CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79500 ECOFLX 500 ML EMPTYING MIXTURE BAG CONTAINER, I.V. KPE DOUGLAS MEDICAL PRODUCTS, INC. C24S0780

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown