BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BAG 250ML

    MDR report key: 24321325 · Received February 12, 2026

    Report

    Report Number
    24321325
    Event Type
    Malfunction
    Date Received
    February 12, 2026
    Date of Event
    August 26, 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

    INFUSION CENTER STAFF REPORTED THAT AFTER SPIKING THE BAG FOR AN ANTIBIOTIC INFUSION, THE CADD PUMP BEGAN ALARMING "AIR-IN-BAG". STAFF REPORTED THAT THE NEW BD BAGS ARE STIFF AND WHEN PRIMED, AIR BUBBLES FORM WHICH CAUSES AIR IN THE TUBING LINE. THIS THEN CAUSES THE CADD PUMP TO ALARM AND FAIL TO DISPENSE THE DOSE OF ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382026 BD BAG 250ML CONTAINER, I.V. KPE GILERO, LLC 1727170105

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Other