BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q SILVERSOAKER

    MDR report key: 1171244 · Received September 17, 2008

    Report

    Report Number
    2026095-2008-00128
    Event Type
    Injury
    Date Received
    September 17, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 21, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. WITHOUT THE ACTUAL PRODUCT, NO DETERMINATION CAN BE MADE AS TO WHAT MAY HAVE OCCURRED. A REVIEW OF THE LOT HISTORY SHOWED NO OTHER COMPLAINTS FOR BLEEDING THIS LOT. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE LOT REPORTED, AND ALL MET SPECIFICATIONS. IF ADD'L INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    A SMALL AMOUNT OF BLOOD WAS NOTED AT THE CATHETER INSERTION SITE AFTER THE CASE WAS COMPLETED. SEVERAL HOURS LATER WHEN THE PT CHANGED POSITIONS, PROFUSE BLEEDING STARTED FROM THE CATHETER SITES. THE BLEEDING WAS STOPPED WITH SUTURES. PT DID NOT REQUIRE FURTHER SURGERY. FILL VOLUME 450 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q SILVERSOAKER INFUSION PUMP MEB I-FLOW CORP. PM028-A 852756

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention