BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2478427 · Received February 21, 2012

    Report

    Report Number
    2026095-2012-00010
    Event Type
    Malfunction
    Date Received
    February 21, 2012
    Date of Event
    January 27, 2012
    Report Date
    January 27, 2012
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: SAMPLE HAS NOT YET BEEN REC¿D, BUT WAS REPORTED TO BE AVAILABLE. RESULTS: WITHOUT THE ACTUAL PRODUCT, AN ANALYSIS CANNOT BE CONDUCTED. CONCLUSION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR THE LOT NUMBER AND INCIDENT REPORTED. THE DEVICE PASSED ALL MFG SPECS PRIOR TO RELEASE. IF ADD¿L INFO PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    DRUG/DILUENT: ROPIVACAINE 0.1%. FILL VOLUME: 400ML. FLOW RATE: UNK. PROCEDURE: TOTAL KNEE ARTHROPLASTY. CATHPLACE: FEMORAL. IT WAS REPORTED THAT THE BOLUS BUTTON WAS STUCK IN THE DEPRESSED POSITION. THE PUMP WAS REMOVED AND REPLACED. START DATE OF INFUSION: (B)(6) 2012, END DATE OF INFUSION: (B)(6) 2012. PT¿S PAIN WAS CONTROLLED WITH A NEW PUMP. NO ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOC 400ML X 1-7ML/HR SAF+5ML/60MIN ELASTOMERIC PUMP MEB I-FLOW CORPORATION 101347300 162934

    Patients

    Seq Age Sex Outcome Treatment
    1