BEUDAMED
    FDA Adverse Event Other Summary report: N

    Q-SYTE LUER ACCESS SITE

    MDR report key: 1415249 · Received July 15, 2009

    Report

    Report Number
    9610847-2009-00046
    Event Type
    Other
    Date Received
    July 15, 2009
    Report Date
    July 6, 2009
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEM
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION HAS BEEN REQUESTED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4)

    Description of Event or Problem · 1

    THE BD Q-STYLE HAD A PROBLEM WITH AIR BUBBLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Q-SYTE LUER ACCESS SITE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON INFUSION THERAPY SYSTEM NA 8268863

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other