BEUDAMED
    FDA Adverse Event Other Summary report: N

    Q-SYTE LUER ACCESS SITE

    MDR report key: 1480125 · Received September 18, 2009

    Report

    Report Number
    9610847-2009-00062
    Event Type
    Other
    Date Received
    September 18, 2009
    Date of Event
    August 26, 2009
    Report Date
    August 28, 2009
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS CURRENTLY BEING DECONTAMINATED. UPON DECONTAMINATION AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE BD Q-SYTE LEAKED FROM THE SEPTUM DURING INJECTION WITH A SYRINGE. THE DEVICE HAD BEEN IN USE FOR 6 HOURS.

    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 SYSTEMS NA 8354558

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Other ANTIBIOTICS