BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BAG 250ML

    MDR report key: 24321324 · Received February 12, 2026

    Report

    Report Number
    24321324
    Event Type
    Malfunction
    Date Received
    February 12, 2026
    Date of Event
    August 28, 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

    PATIENT PRESENTED TO THE INFUSION CENTER AND STATED THAT AFTER HIS BAG HAD BEEN CHANGED AND PT WAS AT HOME AGAIN, 56-MINUTES INTO THE INFUSION TIME, THE PUMP DETECTED "AIR-IN-LINE" AND BEGAN TO ALARM. THE PATIENT CALLED THE INFUSION CENTER HOTLINE, BUT THEY WERE UNABLE TO FIX IT OVER THE PHONE. PT WAS ADVISED TO TURN THE PUMP OFF CAUSING PT TO MISS PART OF THE FIRST DOSE AND ALL OF THIS SECOND DOSE OF ANTIBIOTIC. UPON ARRIVAL, THE PUMP WAS RESET AND PRIMED WITH NEW TUBING. THE PATIENT WAS INFORMED TO KEEP THE BAG UPRIGHT TO TRY TO PREVENT AIR BUBBLES FROM FORMING IN THE BAG WHICH THEN TRAVEL TO THE TUBING. STAFF CONTINUE TO REPORT THAT THE NEW BD BAGS ARE STIFF AND AIR BUBBLES FORM RESULTING IN AIR IN THE TUBING WHICH RESULTS IN THE FAILURE OF THE PUMP TO DISPENSE THE DOSE OF ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382025 BD BAG 250ML CONTAINER, I.V. KPE GILERO, LLC 1727170105

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Other