BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAXCEL

    MDR report key: 2074545 · Received April 21, 2011

    Report

    Report Number
    2074545
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    March 9, 2011
    Report Date
    April 19, 2011
    Manufacturer
    NAVILYST MEDICAL, INC.
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TWO LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER PLACED FOR CHEMOTHERAPY ON (B)(6) 2011. ON (B)(6) 2011, PRIOR TO FIRST CHEMOTHERAPY ADMINISTRATION, PT COMPLAINED OF STINGING WITH NORMAL SALINE ADMINISTRATION THROUGH RED PORT. BLOOD COULD NOT BE WITHDRAWN FROM THE RED PORT. PT UNDERWENT DYE STUDY. CONTRAST INJECTED THROUGH PICC. CONTRAST EXTRAVASATION NOTED FROM LUMEN JUST BELOW BIFURCATION FROM RED PORT. SMALL PIN HOLE NOTED. PICC REMOVED. REQUIRED ANOTHER PICC PLACEMENT ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAXCEL PERIPHERALLY INSERTED CENTRAL CATHETER LJT NAVILYST MEDICAL, INC. 4077709

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention