BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE-W

    MDR report key: 3233844 · Received July 16, 2013

    Report

    Report Number
    2243072-2013-00077
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 17, 2013
    Report Date
    July 16, 2013
    Manufacturer
    BD
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RECEIVED FOR EVAL. HOWEVER, PHOTOS WERE RECEIVED AND ARE PENDING EVAL.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE PT WAS IN SURGERY FOR GYNECOLOGIC REASONS. THE PT WAS PREPPED AND IV WAS STARTED FOR ADMINISTRATION OF ANESTHESIA. THE SURGERY AND IV INFUSION WERE SUCCESSFUL. THE PT WAS QUITE WITHOUT ACTIVE MOVEMENT. WHEN THE PT AWOKE, THE CATHETER WAS DISCONTINUED AND DURING THIS PROCEDURE, THE NURSE FOUND THAT 3CM WERE MISSING FROM THE CATHETER. IMMEDIATELY THE NURSE USED A TOURNIQUET ABOVE THE IV SITE AND AN X-RAY WAS PERFORMED TO DETERMINED THE CATHETERS POSITION. THE CATHETER'S POSITION WAS CONFIRMED BY X-RAY. THE CATHETER WAS SURGICALLY REMOVED. ON (B)(6) 2013, THE PT WAS DISCHARGED FROM THE HOSPITAL. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328095 BD INSYTE-W 18G PERIPHERAL VENOUS CATHETER FOZ BD 2303058

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention