BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP

    MDR report key: 23238295 · Received October 7, 2025

    Report

    Report Number
    9610825-2025-00596
    Event Type
    Malfunction
    Date Received
    October 7, 2025
    Report Date
    December 3, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). DEVICE HISTORY RECORD (DHR): REVIEWED THE DHR FOR BATCH 24L23GED81, THERE IS NO ABNORMALITY AND NO SUCH DEFECT DETECTED AT IN PROCESS AND AT FINAL CONTROL INSPECTION. SAMPLE FOR EVALUATION: RECEIVED ONE SAMPLE OF EASYPUMP II LT 100-50-S-EU/SA WITHOUT ORIGINAL PRIMARY PACKAGING FOR BATCH NUMBER 24L23GED81. OBSERVED WHITE CRYSTALIZE RESIDUE ON THE FILTER. INVESTIGATION RESULT: WHEN THE PUMP WAS UNCLAMPED, THE LEAKAGE WAS OBSERVED FROM THE FILTER WELDED AREA. THE FILTER IS A PURCHASED COMPONENT, AND THUS SUPPLIER WAS NOTIFIED FOR FURTHER INVESTIGATION AND NECESSARY ACTION. IN ADDITION, A CAPA HAS BEEN INITIATED TO ADDRESS THIS MATTER. THIS COMPLAINT IS CONFIRMED. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW- UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE. NOTE: THIS REPORTED IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC. PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFO: UDI NUMBER (B)(4). PREMARKET SUBMISSION # K081905.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: "TTHE PUMP WAS LEAKING AT THE FILTER AND EMPTIED WITHIN A SHORT PERIOD OF TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204119 EASYPUMP PUMP, INFUSION, ELASTOMERIC MEB B BRAUN MELSUNGEN AG 24L23GED81

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown