BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BAG 250ML

    MDR report key: 24321339 · Received February 12, 2026

    Report

    Report Number
    24321339
    Event Type
    Malfunction
    Date Received
    February 12, 2026
    Date of Event
    August 22, 2025
    Report Date
    December 24, 2025
    Manufacturer
    GILERO, LLC
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    STAFF REPORT THAT THE BD BAGS ARE STIFF, AND WHEN PRIMED, AIR BUBBLES FORM WHICH CREATES EXCESSIVE AMOUNTS OF AIR BUBBLES TO ENTER THE IV TUBING LINE. THIS CAUSES THE CADD PUMP TO ALARM AND EITHER INTERRUPT THE INFUSION OR FAIL TO DISPENSE THE DOSE OF MEDICATION TO THE PATIENT. STAFF ATTEMPTED TO MITIGATE THE ISSUE BY ASKING IF OUR HOSPITAL PHARMACY COULD PRIME THE BAG TO CLEAR THE BAG/LINE OF AIR, OR THAT THE BAG BE "OVER-FILLED" TO HELP PUSH OUT THE AIR. BOTH IDEAS WERE INTENDED TO FIND A WAY TO AVOID HAVING TO PRIME THE BAG, IN THE HOPE THAT THE BUBBLES WOULD BE GONE BEFORE THEY SET UP THE PUMP FOR HOME INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382136 BD BAG 250ML CONTAINER, I.V. KPE GILERO, LLC 1727170105

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Other