BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q C-BLOC

    MDR report key: 1056642 · Received June 4, 2008

    Report

    Report Number
    2026095-2008-00068
    Event Type
    Other
    Date Received
    June 4, 2008
    Date of Event
    April 8, 2008
    Report Date
    May 6, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS BEEN RECEIVED FOR EVAL AND INVESTIGATION, AND IS CURRENTLY BEING TESTED. THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. THE REPORT STATED THAT THE BOLUS BUTTON ON THE PCA STUCK IN THE DOWN POSITION DURING USE. NO ADVERSE EVENT OCCURRED. THE RESULTS OF TESTING WILL BE PROVIDED IN A FOLLOW-UP REPORT. THE DEVICE HISTORY RECORD FOR LOT 822312 WAS REVIEWED, AND ALL MANUFACTURING OPERATIONS WERE FOUND TO BE WITHIN SPECIFICATION. THE LOT HISTORY WAS REVIEWED ADN THIS IS THE ONLY COMPLAINT OF A STUCK BUTTON FOR LOT 822312. IN ADDITION, RETAIN SAMPLES FROM LOT 822312 ARE BEING TESTED AND THE RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT. THIS REPORT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    BOLUS STUCK IN DOWN POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOC INFUSION PUMP MEB I-FLOW CORP. CB006 822312

    Patients

    Seq Age Sex Outcome Treatment
    1 Other