BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD NEXIVA CLOSED IV ACCESS SYSTEM

    MDR report key: 1911459 · Received November 23, 2010

    Report

    Report Number
    1710034-2010-00059
    Event Type
    Other
    Date Received
    November 23, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 3, 2010
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REVEALED THAT FACILITY FAILED TO CAP THE END OF THE Y ADAPTER CAUSING THE BLOOD EXPOSURE. A MAILING CONTAINER AND PREPAID LABEL HAS BEEN SENT TO THE CUSTOMER FOR RETURN OF THE SAMPLE. (B)(4).

    Description of Event or Problem · 1

    REPORTED THAT PRODUCT "BLOWS" UP AFTER USING THE POWER INJECTOR. BLOOD EXPOSURE TO A MEMBER OF THE MEDICAL STAFF EYES.

    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 0138395

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other