BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-FLOW SILVERSOAKER

    MDR report key: 2021743 · Received March 11, 2011

    Report

    Report Number
    MW5019814
    Event Type
    Injury
    Date Received
    March 11, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 11, 2011
    Manufacturer
    I-FLOW
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN ON-Q WAS PLACED INTO THE SKIN INTRAOPERATIVELY AND PLACED IN THE SUBPLEURAL REGION. WHEN THE CATHETER WAS FLUSHED BY THE DOCTOR, RESISTANCE WAS FELT AND CATHETER WAS REMOVED. IT WAS THEN NOTICED THAT THE TIP WAS SHEARED AND PROBABLY RETAINED IN THE BODY. IT WAS DETERMINED, THERE WAS MORE RISK INVOLVED IN REMOVING THE TIP OF THE ON-Q SILVERSOAKER CATHETER, PT WAS MADE AWARE AND AGREED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-FLOW SILVERSOAKER ON-Q PUMP MEB I-FLOW 5001708 0B2718

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability