BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD Q-SYTE LUER ACCESS SPLIT SEPTUM

    MDR report key: 2066597 · Received April 12, 2011

    Report

    Report Number
    9610847-2011-00023
    Event Type
    Other
    Date Received
    April 12, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 25, 2011
    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

    THE SAMPLE IS AVAILABLE FOR EVAL. ADD'L INFO REGARDING THIS INCIDENT HAS BEEN REQUESTED. UPON RECEIPT OF THE SAMPLE AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    A SYRINGE WAS INSERTED INTO THE BD Q-SYTE DEVICE IN PREPARATION TO DRAW BLOOD. DURING THE DRAW, THERE WAS ONLY AIR INSIDE THE SYRINGE AND NO BLOOD. THE USER BELIEVED THERE MAY HAVE BEEN DAMAGE TO THE BD Q-SYTE DEVICE.

    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 Other