BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD NEXIVA CLOSED IV ACCESS SYSTEM

    MDR report key: 2182541 · Received July 20, 2011

    Report

    Report Number
    1710034-2011-00064
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 20, 2011
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS DESTROYED, AND THEREFORE, NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFO REGARDING THIS INCIDENT HAS BEEN REQUESTED. IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE ER NIGHT SUPERVISOR PLACED THE BD NEXIVA DEVICE INTO THE PT AND ATTACHED A SYRINGE TO FLUSH. ASPIRATION AND BLOOD CONFIRMATION WAS FINE, HOWEVER, WHEN HE ATTEMPTED TO FLUSH THE LINE CLEAR, A MIXTURE OF SALINE AND BLOOD SPLASHED HIM IN THE EYE. THE CLINICIAN VERIFIED THAT THE BD Q-SYTE DEVICE WAS SECURELY ATTACHED TO THE LUER ADAPTER AND THAT THE SYRINGE FULLY LUER-LOCKED TO THE BD Q-SYTE DEVICE. THE CLINICIAN ALSO STATED THAT THE SYRINGE ASPIRATED WITHOUT RESISTANCE, BUT LEAKED AND SPLASHED DURING THE FLUSH. INCIDENTS SUCH AS THIS HAVE HAPPENED BEFORE IN THE DEPARTMENT, BUT THIS WAS THE FIRST RESULTING IN MUCOCUTANEOUS EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD NEXIVA CLOSED IV ACCESS SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS NA 0351894

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other