BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD Q-SYTE LUER ACCESS SPLIT SEPTUM

    MDR report key: 2359820 · Received November 30, 2011

    Report

    Report Number
    9610847-2011-00092
    Event Type
    Injury
    Date Received
    November 30, 2011
    Date of Event
    November 17, 2011
    Report Date
    November 30, 2011
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    TWO BD Q-SYTE DEVICES WERE ATTACHED TO A STOPCOCK FOR HEPARINE LOCK. A 20CC LUER LOCK SYRINGE WAS ATTACHED TO ONE OF THE BD Q-SYTE DEVICES. THE USER WITHDREW THE PLUNGER TO CHECK FOR NO CLOGGING IN THE LINE BEFORE BEGINNING THE INFUSION OF THE ANTI-CANCER AGENT. A 6CC OF AIR WAS THEN INTRODUCED INTO THE SYRINGE AND EXTENSION TUBING. THE USER SUSPECTED THE CONNECTION BETWEEN THE SYRINGE AND BD Q-SYTE DEVICE AND TRIED TO TIGHTEN THEM. THE CONNECTION KEPT SLIPPING. AFTER REMOVING THE AIR IN THE LINE, THE USER CHANGED TO A NEW BD Q-SYTE DEVICE. THERE WAS NO HARM TO THE PT AS A RESULT OF THIS INCIDENT.

    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 1060030

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other ANTI-CANCER AGENT