BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYTE-W

    MDR report key: 83584 · Received April 9, 1997

    Report

    Report Number
    1710034-1997-00012
    Event Type
    Injury
    Date Received
    April 9, 1997
    Date of Event
    March 15, 1997
    Report Date
    March 24, 1997
    Manufacturer
    BECTON DICKINSON VASCULAR ACCESS, INC.
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IV STARTED WITHOUT DIFFICULTY. THE NURSE NOTICED AFTER ATTACHING THE EXTENSION SET A SMALL AMOUNT OF BLOOD UNDER THE DRSSING. SHE PULLED BACK THE DRESSING AND NOTED THAT THE GREEN WINGED HUB PORTION OF THE CATHETER WAS SEPARATED FROM THE CATHETER. A CUTDOWN PROCEUDRE WAS PERFORMED AND THE CATHETER PIECE WAS NOT FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYTE-W PERIPHERAL VENOUS ACCESS CATHETER FOZ BECTON DICKINSON VASCULAR ACCESS, INC. NA H6NB810

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention