BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I FLOW

    MDR report key: 1723173 · Received June 9, 2010

    Report

    Report Number
    MW5016315
    Event Type
    Malfunction
    Date Received
    June 9, 2010
    Date of Event
    June 7, 2010
    Report Date
    June 9, 2010
    Manufacturer
    I FLOW CORPORATION
    Product Code
    BSO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PLACEMENT OF ON-Q PUMP CATHETER, TUNNELER WITH SHEATH, FRACTURED WHEN SEPARATING SHEATH FROM CATHETER RESULTING IN TWO PIECES BEING RETAINED WITHIN THE ABDOMINAL WALL. APPROXIMATELY 8-9 CM OF THE SHEATH WAS LEFT IN THE ABDOMINAL WALL ON ONE OF THE PIECES, AND APPROXIMATELY 4-5 CM WAS LEFT ON THE OTHER PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I FLOW TUNNELER WITH SHEATH BSO I FLOW CORPORATION 884875

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other