BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q PAINBUSTER SS 2.5IN 100ML, 2ML/HR

    MDR report key: 2508702 · Received March 26, 2012

    Report

    Report Number
    2026095-2012-00041
    Event Type
    Malfunction
    Date Received
    March 26, 2012
    Date of Event
    February 13, 2012
    Report Date
    March 1, 2012
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: SAMPLE HAS NOT YET BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE. RESULTS: WITHOUT THE ACTUAL PRODUCT, AN ANALYSIS CANNOT BE CONDUCTED. CONCLUSIONS: IF ADD'L INFO PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A F/U REPORT.

    Description of Event or Problem · 1

    DRUG/DILUENT: BUPIVACAINE .5%. FILL VOLUME: 100ML. FLOW RATE: 2.0ML/HR. PROCEDURE: BI-LATERAL HERNIA. CATHPLACE: RIGHT AND LEFT AB. IT WAS REPORTED THAT THE PT HAD TWO PUMPS AND THAT ONE EMPTIED FASTER THAN THE OTHER. NO ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER SS 2.5IN 100ML, 2ML/HR ELASTOMERIC PUMP MEB I-FLOW CORPORATION 101370100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR