BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD Q-SYTE LUER ACCESS SPLIT SEPTUM

    MDR report key: 2236965 · Received September 2, 2011

    Report

    Report Number
    9610847-2011-00055
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 25, 2011
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYS
    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. UPON RECEIPT OF THE SAMPLE AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING DIALYSIS. A NYPRO SYRINGE WAS ATTACHED TO THE BD Q-SYTE FEMALE LUER AND A BLOOD ACCESS CATHETER (USED FOR DIALYSIS) WAS ATTACHED TO THE BD Q-SYTE MALE LUER. WHEN THE USER PULLED THE PLUNGER OF THE SYRINGE TO MAKE SURE THERE WAS NO LEAKAGE FROM THE CATHETER, AIR WAS INTRODUCED INTO THE SYRINGE. DAMAGE TO THE BD Q-SYTE DEVICE IS SUSPECTED.

    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 SYS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other