BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAINBUSTER

    MDR report key: 1825990 · Received August 31, 2010

    Report

    Report Number
    2026095-2010-00120
    Event Type
    Other
    Date Received
    August 31, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 11, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ON-Q PAIN BUSTER PUMP WAS NOT RETURNED FOR EVALUATION AND INVESTIGATION. WITHOUT THE ACTUAL PRODUCT OR A LOT NUMBER, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORD AND THE LOT HISTORY CANNOT BE REVIEWED. PER THE DIRECTION FOR USE (DFU), (PN:1304265, REV. L), UNDER CONTRAINDICATIONS STATED: "ON-Q IS NOT INTENDED FOR INTRAVASCULAR DELIVERY." THE CATHETER SITE LABEL (DWG: 1305466, REV. C) IS INCLUDED WITH ALL I-FLOW PUMPS STATING, "NO IV ACCESS". IF ADDITIONAL INFORMATION BECOMES AVAILABLE IN THE FUTURE, WE WILL REOPEN THIS COMPLAINT.

    Description of Event or Problem · 1

    PUMP WAS FOUND CONNECTED TO THE PT'S IV LINE IN THE HAND. NO ADVERSE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER ELASTOMERIC PUMP MEB I-FLOW CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other