BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q C-BLOC WITH SELECT-A-FLOW

    MDR report key: 1385958 · Received May 12, 2009

    Report

    Report Number
    2026095-2009-00109
    Event Type
    Other
    Date Received
    May 12, 2009
    Date of Event
    April 1, 2009
    Report Date
    April 14, 2009
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER. THE DEVICE INVOLVED IN THIS INCIDENT WAS NOT AVAILABLE FOR EVALUATION AND INVESTIGATION. WITHOUT THE ACTUAL PRODUCT OR LOT NUMBER, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. PER THE DIRECTIONS FOR USE, (1304265, REV. G), "ON-Q IS NOT INTENDED FOR INTRAVASCULAR DELIVERY." CATHETER SITE LABEL (1305466, REV. C) IS INCLUDED WITH ALL I-FLOW PUMPS STATING, "CATHETER SITE - NO IV ACCESS". IF ADDITIONAL INFORMATION THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ON-Q CB004 WAS HOOKED UP TO IV TUBING AND INFUSED LOCAL ANESTHETIC TO THE PATIENT FOR APPROXIMATELY 2 HOURS. THE PATIENT DID NOT ACQUIRE ANY TOXICITY ISSUES AND HAD A POSITIVE OUTCOME. THE PUMP WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOC WITH SELECT-A-FLOW INFUSION PUMP MEB I-FLOW CORP. CB004 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other