BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD Q-SYTE LUER ACCESS SPLIT SEPTUM

    MDR report key: 2132551 · Received June 9, 2011

    Report

    Report Number
    9610847-2011-00041
    Event Type
    Injury
    Date Received
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE RECEIVED FOR EVALUATION ON (B)(4) 2011 AND SENT FOR DECONTAMINATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. INTERNAL FILE NUMBER: (B)(4). DATE SUBMITTED: (B)(4) 2011.

    Description of Event or Problem · 1

    THE BD Q-STYLE WAS CONNECTED TO A PERFUSION LINE AND A PERFUSION SYRINGE WAS CONNECTED TO THE BD Q-SYTE DEVICE FOR A PT IN THE ICU. DURING INFUSION, THE UNIT WAS FOUND LEAKING. ACCORDING TO THE CLINICIAN, THE LEAKAGE WAS EXCESSIVE. THERE WAS NO HARM TO THE PT AS A RESULT OF THIS INCIDENT. THE CURRENT PT STATUS IS WELL.

    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 3 YR Other