BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q-SYTE CLOSED LUER ACCESS DEVICE

    MDR report key: 11263694 · Received February 1, 2021

    Report

    Report Number
    1710034-2021-00069
    Event Type
    Malfunction
    Date Received
    February 1, 2021
    Date of Event
    January 6, 2021
    Report Date
    March 2, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FPA
    UDI-DI
    30382903851004
    PMA / PMN Number
    K013621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 1/15/2021. H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED ONE Q-SYTE AND THREE PHOTOS. DURING THE VISUAL/MICROSCOPIC EXAMINATION, IT WAS OBSERVED THAT THERE WAS NO SLIT IN THE TOP DISK, CONFIRMING THE REPORTED DEFECT. MISSING SLITS CAN OCCUR DURING THE MANUFACTURING PROCESS. THEREFORE, THE DEFECT WAS RELATED TO MANUFACTURING. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A Q-SYTE CLOSED LUER ACCESS DEVICE HAD WAS DEFORMED AND HAD FLOW ISSUES DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "ACCORDING TO THE CUSTOMER'S REPORT, THE SEPTUM WAS NOT OPENED (IT SEEMS THAT THERE IS NO SLIT IN Q-SYTE)."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A Q-SYTE CLOSED LUER ACCESS DEVICE HAD WAS DEFORMED AND HAD FLOW ISSUES DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "ACCORDING TO THE CUSTOMER'S REPORT, THE SEPTUM WAS NOT OPENED (IT SEEMS THAT THERE IS NO SLIT IN Q-SYTE)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153480 Q-SYTE CLOSED LUER ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 385100 0119936 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1