BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD Q-SYTE LUER ACCESS SPLIT-SEPTUM

    MDR report key: 1641156 · Received March 23, 2010

    Report

    Report Number
    9610847-2010-00014
    Event Type
    Other
    Date Received
    March 23, 2010
    Date of Event
    February 26, 2010
    Report Date
    March 8, 2010
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF INVESTIGATION. (B)(4). DATE SUBMITTED: 03/23/2010.

    Description of Event or Problem · 1

    "BLOOD LEAKAGE AND AIR INTRODUCTION WAS SEEN BETWEEN FEMALE LUER OF Q-SYTE AND MALE LUER OF ANOTHER DEVICE DURING THE DIALYSIS, PLEASE CHECK HOUSING/SEPTUM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD Q-SYTE LUER ACCESS SPLIT-SEPTUM INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention