BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHARMACY TRANSFER TUBING, LARGE BORE UNIVERSAL SPIKE

    MDR report key: 22046790 · Received May 19, 2025

    Report

    Report Number
    MW5170573
    Event Type
    Injury
    Date Received
    May 19, 2025
    Date of Event
    May 4, 2025
    Report Date
    May 15, 2025
    Manufacturer
    US INFUSION LLC. D/B/A TRUECARE BIOMEDIX-USA
    Product Code
    FPA
    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/PARTICULATES WERE FOUND IN SEVERAL BATCHED IV EPIDURAL PRODUCTS TO THE POINT WHERE WE DISCARDED THE BATCHED PRODUCTS ENTIRELY BECAUSE WE DID NOT FEEL IT WAS SAFE FOR PATIENT USE. OUR NEW BATCHING PROCESS INCLUDES POOLING THE IV EPIDURAL COMPOUND AND THEN FILLING EMPTY BAGS USING A BAXTER REPEATER PUMP. WE ARE UNSURE IT IS RELATED TO STAFF TECHNIQUE, PRODUCT DESIGN, OR PROBLEM WITH THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77440 PHARMACY TRANSFER TUBING, LARGE BORE UNIVERSAL SPIKE SET, ADMINISTRATION, INTRAVASCULAR FPA US INFUSION LLC. D/B/A TRUECARE BIOMEDIX-USA 10160601

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention