BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q C-BLOC

    MDR report key: 1200215 · Received October 1, 2008

    Report

    Report Number
    2026095-2008-00163
    Event Type
    Other
    Date Received
    October 1, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 2, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER. THE REPORT DID NOT PROVIDE ANY SPECIFIC INFORMATION CONCERNING THE PUMP LOT NUMBER. WITHOUT THE ACTUAL PRODUCT OR DETAILS OF THE INCIDENT, AN ANALYSIS CANNOT BE CONDUCTED. IT WAS REPORTED THAT THE SAMPLE WAS AVAILABLE FOR EVALUATION, BUT HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. COMPLAINT IS UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BOLUS BUTTON WAS STUCK IN THE DOWN POSITION FOR APPROXIMATELY 1.5 HOURS. NURSE CLAMPED OFF PUMP AND CALLED ANESTHESIOLOGIST. PUMP WAS REMOVED. NO ADVERSE EVENT REPORTED AT TIME OF COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOC INFUSION PUMP MEB I-FLOW CORP. CB003 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK