BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYTE AUOTGUARD

    MDR report key: 88730 · Received April 29, 1997

    Report

    Report Number
    1710034-1997-00015
    Event Type
    Injury
    Date Received
    April 29, 1997
    Date of Event
    March 27, 1997
    Report Date
    April 1, 1997
    Manufacturer
    BECTON DICKINSON VASCULAR ACCESS, INC.
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE A CATHETER WAS BEING WITHDRAWN, THE DR NOTICED THAT APPROX 1 CM OF THE CATHETER WAS EITHER SHEARED OR BROKEN. THE PT WAS X-RAYED AND THE CATHETER PIECE WAS LOCATED IN THE VEIN OF HER UPPER ARM. A CUTDOWN PROCEDURE WAS PERFORMED AND THE CATHETER PIECE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYTE AUOTGUARD PERIPHERAL VENOUS ACCESS CATHETER FOZ BECTON DICKINSON VASCULAR ACCESS, INC. NA H6BA550

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention