BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q C-BLOC W/SAF, 400ML, 2-14 ML/HR

    MDR report key: 2432759 · Received January 6, 2012

    Report

    Report Number
    2026095-2011-00466
    Event Type
    Malfunction
    Date Received
    January 6, 2012
    Report Date
    December 8, 2011
    Manufacturer
    I-FLOW, LLC.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHARMACIST

    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 EVALUATION PENDING RETURN OF PRODUCT. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE FILED WHEN INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DRUG/DILUENT: UNKNOWN. FILL VOLUME: 550 ML. FLOW RATE: 10ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. THE PAINBALL INFUSED 20% FASTER ACCORDING TO THE DOCTOR. THE DOCTOR REPORTED THAT THE PUMP RAN 10 HOURS SHORT. PATIENT CONTACT. NO ADVERSE EVENT. DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOC W/SAF, 400ML, 2-14 ML/HR ELASTOMERIC PUMP MEB I-FLOW, LLC. 101347200 172185

    Patients

    Seq Age Sex Outcome Treatment
    1