BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q C-BLOC SAF/PCA, 400X 1-7+5ML/60MIN

    MDR report key: 2433373 · Received January 9, 2012

    Report

    Report Number
    2026095-2012-00002
    Event Type
    Malfunction
    Date Received
    January 9, 2012
    Date of Event
    August 15, 2011
    Report Date
    December 15, 2011
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    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. PRODUCT PENDING RECEIPT. CONCLUSIONS: A F/U REPORT WILL BE FILED WHEN INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DRUG/DILUENT: ROPIVACAINE 0.2%. FILL VOLUME: 550 ML. FLOW RATE: 7 ML. PROCEDURE: UNK. CATHPLACE: UNK. AFTER THE PUMP WAS PRIMED, THE BOLUS BUTTON DID NOT STICK. PT CONTACT. PUMP WAS REMOVED AND REPLACED. NO ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOC SAF/PCA, 400X 1-7+5ML/60MIN ELASTOMERIC PUMP MEB I-FLOW, LLC 5001651 142618

    Patients

    Seq Age Sex Outcome Treatment
    1