BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BAG 250ML

    MDR report key: 24321340 · Received February 12, 2026

    Report

    Report Number
    24321340
    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

    PATIENT RETURNED TO THE OUTPATIENT INFUSION CENTER STATING THAT THE ANTIBIOTIC BAG HAD BEEN CHANGED THE DAY BEFORE, AND 20-MINUTES AFTER PT GOT HOME, THIS CADD PUMP BEGAN ALARMING "AIR-IN-LINE". PT REPORTED THAT IT INTERRUPTED MOST ALL OF THE INTENDED ANTIBIOTIC INFUSION. THE PATIENT STATED THAT VISIBLE AIR WAS IN THE TUBING AND COMPLAINED THAT THIS IS THE SECOND TIME THIS HAS HAPPENED RECENTLY. STAFF REALIZED THAT SINCE THE HOSPITAL CHANGED BD BAGS, THERE HAS BEEN A NOTICEABLE INCREASE IN PATIENT COMPLAINTS ABOUT THE "AIR-IN-LINE" ALARMS. UPON CLOSER EXAMINATION, THEY NOTE THAT THE BD BAGS ARE "STIFF" AND ARE NOT OVER-FILLED WHICH THEY FEEL IS LEADING TO AIR BUBBLES WHICH ENTER THE IV TUBING LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382137 BD BAG 250ML CONTAINER, I.V. KPE GILERO, LLC 727170105

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Other