BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP ELASTOMERIC DEVICE

    MDR report key: 16337684 · Received February 8, 2023

    Report

    Report Number
    MW5114815
    Event Type
    Malfunction
    Date Received
    February 8, 2023
    Date of Event
    January 24, 2023
    Report Date
    February 6, 2023
    Manufacturer
    B. BRAUN MEDICAL INDUSTRIES SDN. BHD
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTED THAT EASYPUMP WAS LEAKING UPON ARRIVAL. THERE HAVE BEEN OTHER REPORTS OF LEAKY DEVICES SUCH AS THIS. PATIENT DISCARDED EASYPUMP AND USED ANOTHER DOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066725 EASYPUMP ELASTOMERIC DEVICE PUMP, INFUSION, ELASTOMERIC MEB B. BRAUN MEDICAL INDUSTRIES SDN. BHD 100/200

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male