BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE¿ AUTOGUARD¿ 18G X 1.16 IN.

    MDR report key: 5240224 · Received November 20, 2015

    Report

    Report Number
    1710034-2015-00020
    Event Type
    Injury
    Date Received
    November 20, 2015
    Date of Event
    September 15, 2015
    Report Date
    December 3, 2015
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 4071729. AS THERE WAS NO ACTUAL SAMPLE RETURNED FOR EVALUATION, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    EVALUATION: A SAMPLE IS AVAILABLE FOR EVALUATION BUT HAS NOT BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION OF THE BD INSYTE AUTOGUARD, THE DEVICE WAS REMOVED AFTER NO BLOOD RETURN WAS OBSERVED. A PIECE OF THE CATHETER REMAINED IN THE PATIENT'S ARM. A SKIN INCISION WAS MADE FOR REMOVAL OF THE BROKEN PIECE. STERISTRIPS AND A DRESSING WERE PLACED TO THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768718 BD INSYTE¿ AUTOGUARD¿ 18G X 1.16 IN. INTRAVENEOUS CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4071729

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention