BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP 270/10

    MDR report key: 16278831 · Received January 31, 2023

    Report

    Report Number
    MW5114610
    Event Type
    Malfunction
    Date Received
    January 31, 2023
    Date of Event
    November 11, 2022
    Report Date
    January 29, 2023
    Manufacturer
    B. BRAUN MEDICAL INDUSTRIES SDN. BHD.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FOUND LIQUID AROUND ONE OF THE DOSES WHEN CHECKING DOSES AFTER COMPOUNDING. AFTER WATCHING IT FURTHER, FOUND THAT IT WAS LEAKING FROM THE END WHERE THE TUBING IS ATTACHED. NO CRACKS OR DEFECTS WERE VISIBLE. HAD TECH REMAKE ONE DOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903144 EASYPUMP 270/10 PUMP, INFUSION, ELASTOMERIC MEB B. BRAUN MEDICAL INDUSTRIES SDN. BHD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female