BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA 3-WAY STOPCOCK WITH BD Q-STYLE

    MDR report key: 4230388 · Received October 22, 2014

    Report

    Report Number
    2243072-2014-00264
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    August 15, 2014
    Report Date
    October 21, 2014
    Manufacturer
    BD
    Product Code
    FMG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS AVAILABLE FOR EVAL. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. OF NOTE, MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO AND NO FURTHER INFO IS AVAILABLE. A QUALITY NOTIFICATION REVIEW WAS DONE ON THE REPORTED LOT NUMBER 3092105B57 AND NO IRREGULARITIES WERE FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A BD CONNECTA 3-WAY STOPCOCK WITH BD Q-STYLE DURING A SEDATION PROCEDURE FOR A FRACTURED BODY PART, THAT THE MEDICATION, PROPOFOL, BEGAN LEAKING FROM THE BD Q-STYLE EXPOSING THE PT AND THE CLINICIAN TO BLOOD AND MEDICATION. THE PROPOFOL LEAK CAUSED THE PT TO WAKE UP DURING THE SEDATION PROCEDURE. THE BD Q-STYLE WAS CHANGED ON THE PT'S IV LINE AND AS OF THIS DATE THERE HAS BEEN NO FURTHER REPORT OF ADDITIONAL MEDICAL INTERVENTIONS OR ADVERSE EVENTS FOR EITHER THE PT OR THE CLINICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670867 BD CONNECTA 3-WAY STOPCOCK WITH BD Q-STYLE LUER ACCESS SPLIT SEPTUM DEVICE FMG BD 3092105B7

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other