BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q

    MDR report key: 2424526 · Received December 30, 2011

    Report

    Report Number
    2424526
    Event Type
    Malfunction
    Date Received
    December 30, 2011
    Date of Event
    July 12, 2011
    Report Date
    December 30, 2011
    Manufacturer
    I-FLOW
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PER PHONE CONVERSATION PATIENT STATED THAT ON-Q I-FLOW PAIN PUMP WAS LEAKING FROM DIAL. RN STATES THAT PUMP WAS LEAKING FROM DIAL SITE. ON-Q PUMP WAS LEAKING OUT THE OPENING IN THE BACK OF THE REGULATOR VALVE. PUMP IS BEING SENT BACK TO MANUFACTURER FOR EVALUATION AND EXCHANGE. ON-Q 400ML LOT #152678.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q ELASTOMERIC PUMP MEB I-FLOW * 152678

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR