BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q

    MDR report key: 2137278 · Received June 14, 2011

    Report

    Report Number
    2137278
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    April 11, 2011
    Report Date
    June 14, 2011
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    I-FLOW ON-Q PAIN PUMP, PART #5001788, LOT #112951 WAS CLAMPED OFF BUT STILL LEAKED THE MEDICATION INSIDE THE PUMP. THIS OCCURRED BEFORE PATIENT CONTACT, AFTER FILLING THE PUMP IN PHARMACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PUMP, INFUSION, ELASTOMERIC MEB I-FLOW CORPORATION * 112951

    Patients

    Seq Age Sex Outcome Treatment
    1 *