BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP

    MDR report key: 23103975 · Received September 20, 2025

    Report

    Report Number
    9610825-2025-00550
    Event Type
    Malfunction
    Date Received
    September 20, 2025
    Date of Event
    August 8, 2025
    Report Date
    September 20, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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). REVIEWED THE DHR FOR BATCH NUMBERS 25A09GED81 AND 25B17GED81, THERE IS NO ABNORMALITY AND NO SUCH DEFECT DETECTED AT IN PROCESS AND AT FINAL CONTROL INSPECTION. NO SAMPLES RECEIVED AND NO MEANINGFUL PICTURE AVAILABLE FOR A PROPER EVALUATION. THE INVESTIGATION WAS ONLY DONE BASED ON COMPLAINT DESCRIPTION AND BATCH MANUFACTURING RECORD REVIEW AND HISTORICAL DATA. THERE ARE MULTIPLE POTENTIAL ROOT CAUSE FOR THIS DEFECT. 1. VALVE LEAKAGE : A CAPA HAS BEEN INITIATED TO ADDRESS THIS DEFECT. 2. PIN HOLE AT SILICON SLEEVE: CORRECTIVE ACTION ALREADY INITIATED AND COMPLETED IN ADDRESSING THIS DEFECT. 3. LEAK AT FILTER: A CAPA HAS BEEN INITIATED TO ADDRESS THIS DEFECT. AS NEITHER COMPLAINT SAMPLE NOR PICTURE WAS RECEIVED, FURTHER INVESTIGATION IS NOT POSSIBLE TO IDENTIFY THE LEAK. HENCE, THE COMPLAINT IS CLASSIFIED AS NOT CONFIRMED. THE COMPLAINT BATCH SHOWS NO ABNORMALITY. 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: "LEAK OF THE PUMP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1991408 EASYPUMP PUMP, INFUSION, ELASTOMERIC MEB B BRAUN MELSUNGEN AG 25B17GED81

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown