BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q C-BLOC 600ML, 1-7 ML/HR SAF +1-7ML/HR

    MDR report key: 3111250 · Received May 8, 2013

    Report

    Report Number
    2026095-2013-00088
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    January 21, 2013
    Report Date
    April 8, 2013
    Manufacturer
    I-FLOW LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD, RESULT, CONCLUSION: THE SAMPLE WILL NOT BE RETURNED. A DEVICE HISTORY REVIEW IS PENDING INVESTIGATION AT THIS TIME. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DRUG/DILUENT: ROPIVACAINE 0.2%; FILL VOLUME: 600 ML; FLOW RATE: 5.0 ML; PROCEDURE: SMALL BOWEL RESECTION; CATHPLACE: UNK. THE CLINICAL EDUCATOR AT (B)(6) MEDICAL: (B)(6) REPORTED THAT THEY HAD AN INFECTION WITH AN ON Q PROCEDURE AND WAS ATTRIBUTED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202392 ON-Q C-BLOC 600ML, 1-7 ML/HR SAF +1-7ML/HR ELASTOMERIC PUMP MEB I-FLOW LLC CB6007 0200539140

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other