BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q

    MDR report key: 2137310 · Received June 14, 2011

    Report

    Report Number
    2137310
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    April 21, 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 MODEL# CB-6004, LOT#112951, EXP. DATE: 2/13. PUMP RETURNED AS DEFECTIVE BECAUSE THE "SELECT-A-FLOW" RATE CONTROLLER SPINS FREELY AND WILL NOT CLICK INTO A SPECIFIC RATE. WITHOUT A DEFINITE CLICK, THE MEDICATION WILL NOT FLOW FROM THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PUMP, INFUSION, ELASTOMERIC MEB I-FLOW CORPORATION CB-6004 112951

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR