BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURE EVA CONTAINER 250 ML MILLILITRE(S)

    MDR report key: 22003257 · Received May 12, 2025

    Report

    Report Number
    MW5170198
    Event Type
    Injury
    Date Received
    May 12, 2025
    Manufacturer
    THE METRIX COMPANY
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FLOATERS/PARTICLES WERE FOUND UPON INSPECTION AFTER COMPOUNDING MULTIPLE IV EPIDURAL BATCHES AND STAND ALONE IV COMPOUNDS WITH THE EXACTAMIX EVA AND SECURE EVA EMPTY BAGS. THERE DOESN'T SEEM TO BE ANY PHYSICAL DEFORMITY WITH THE BAGS OR AN ISSUE OF TECHNICIAN TECHNIQUE. POSSIBLY THERE COULD BE AN ISSUE OF THE BAG BEING TOO EASY TO SCRAPE ALONG THE WALL AFTER THE PORT IS PUNCTURED. THE PRESENCE OF THE PARTICLES/FLOATERS IS UNACCEPTABLE FOR PATIENT USE AS IT COULD CAUSE PATIENT HARM IF THE FLOATERS/PARTICLES ENTER THE PATIENT. REF REPORT: MW5170197.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241142 SECURE EVA CONTAINER 250 ML MILLILITRE(S) CONTAINER, I.V. KPE THE METRIX COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention