BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP

    MDR report key: 24173690 · Received January 24, 2026

    Report

    Report Number
    9610825-2026-00007
    Event Type
    Malfunction
    Date Received
    January 24, 2026
    Report Date
    January 24, 2026
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    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 25B05GED91, THERE IS NO SUCH DEFECT DETECTED AT IN PROCESS AND FINAL CONTROL INSPECTION PERTAINING PRODUCT LEAKAGE. NO SAMPLE WAS RECEIVED FOR FURTHER INVESTIGATION. HOWEVER, A VIDEO CLIP WAS PROVIDED IN THE CC NOTIFICATION SHOWING LEAK AT THE FILLING PORT. INVESTIGATION RESULTS: NO COMPLAINT SAMPLE WAS GIVEN BUT ONE VIDEO WAS ATTACHED IN THE CC NOTIFICATION TO INDICATE THE SOLUTION WAS LEAKING OUT FROM THE FILLING PORT OF THE SAMPLE. ACCORDING TO THE CUSTOMER'S DESCRIPTION, LEAKAGE WAS OBSERVED AT THE FILLING PORT WHEN FILLING THE PUMP WITH CHEMOTHERAPY DRUGS. BASED ON THE VIDEO, LEAKAGE WAS OBSERVED AT THE FILLING PORT AREA WHICH WAS CONNECTED TO A CONNECTOR DURING THE FILLING PROCESS. THE LEAKAGE AT THE FILLING PORT AREA COULD BE DUE TO THE CRACK AT FILLING PORT. CRACK AT FILLING PORT IS A KNOWN ISSUE AND CORRECTIVE ACTION IS IN PLACE TO ADDRESS THE ISSUE. CONCLUSION: NO COMPLAINT SAMPLE WAS RETURNED FOR INVESTIGATION, BUT A VIDEO WAS RECEIVED. LEAKAGE WAS OBSERVED FROM THE FILLING PORT DURING THE FILLING PROCESS. THEREFORE, THIS COMPLAINT IS CLASSIFIED AS 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. 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: "AFTER FILLING IT COMPLETELY (WE USUALLY FILL IT TO 220 ML), IT STARTED TO LEAK FROM THE FILLING OPENING NEXT TO THE SHUT-OFF VALVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234829 EASYPUMP PUMP, INFUSION, ELASTOMERIC MEB B BRAUN MELSUNGEN AG 25B05GED91

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown