BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVC KIT: 3-LUMEN 7 FR X 20 CM

    MDR report key: 3131168 · Received October 24, 2006

    Report

    Report Number
    3131168
    Event Type
    Injury
    Date Received
    October 24, 2006
    Date of Event
    September 2, 2006
    Report Date
    October 23, 2006
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    GBP
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT UNDERWENT A LEFT INTERNAL JUGULAR APPROACH. UPON INSERTION, THE SPRING WIRE GUIDE 'FRAYED" DURING THE PROCEDURE AND A 2.5CM PIECE OF THE WIRE WAS LEFT IN SOFT TISSUE OF THE LEFT NECK. THE PT WAS TAKEN TO THE OPERATING ROOM. USING FLUOROSCOPY, A CUT DOWN WAS PERFORMED TO REMOVE THE PORTION OF WIRE. USING A DIFFERENT INSERTION SITE ANOTHER MULTI LUMEN CATHETER WAS PLACED FOR TEMPORARY INFUSION USE. MFR 1036844-2006-00079.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 3-LUMEN 7 FR X 20 CM ADULT MULTI-LUMEN CATHETER PRODUCTS GBP ARROW INTERNATIONAL, INC. NA RF0609027

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention