BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD Q-STYLE LUER ACCESS SPLIT SEPTUM

    MDR report key: 2441222 · Received January 31, 2012

    Report

    Report Number
    9610847-2012-00007
    Event Type
    Injury
    Date Received
    January 31, 2012
    Date of Event
    January 13, 2012
    Report Date
    January 27, 2012
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    LJS
    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 LINE WAS CONNECTED TO THE PT (B)(6) 2012 IN THE (B)(6) DEPARTMENT. THE CVC WAS PLACED INTO THE SUBSLAVIAN VESSEL AND A SYRINGE PUMP WAS PLACED NEAR THE PT'S FEET. THE BD Q-STYLE DEVICE, STOPCOCK, FILTER, TUBE AND ADD'L STOPCOCK PORTIONS OF THE PT'S LINE WERE EXCHANGED (B)(6) 2012. TWENTY HOURS AFTER THE EXCHANGE, DURING THE INFUSION, THE PT'S EKG MONITOR/PRESSURE DOWN ALARM ACTIVATED, AND LEAKAGE WAS FOUND ON THE PT'S BEDDING FROM THE BD Q-STYLE DEVICE. THE PT'S BLOOD PRESSURE WENT DOWN RAPIDLY AND A FAST FLUSH WAS CONDUCTED WITH THE SYRINGE PUMP. WITH THIS TREATMENT, THE PT'S BLOOD PRESSURE WENT BACK TO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD Q-STYLE LUER ACCESS SPLIT SEPTUM INTRAVASCULAR CATHETER LJS BECTON DICKINSON INFUSION THERAPY SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other DOBUTAMINE1.8ML| DOPAMINE 1.8ML| GLUCOSE BASE 36.4ML