BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q-SYTE 15CM SMALL BORE BI-EXT SET

    MDR report key: 9519874 · Received December 26, 2019

    Report

    Report Number
    9610847-2019-00761
    Event Type
    Malfunction
    Date Received
    December 26, 2019
    Date of Event
    December 6, 2019
    Report Date
    February 6, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K142527
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT Q-SYTE 15CM SMALL BORE BI-EXT SET HAD BLOOD BACKFLOW. THIS OCCURRED ON 10 OCCASIONS AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLOOD BACK FLOW SEEN FREQUENTLY IN Q SYTE EXTENSIONS.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT Q-SYTE 15CM SMALL BORE BI-EXT SET HAD BLOOD BACKFLOW. THIS OCCURRED ON 10 OCCASIONS AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLOOD BACK FLOW SEEN FREQUENTLY IN Q SYTE EXTENSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316970 Q-SYTE 15CM SMALL BORE BI-EXT SET INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 9078800

    Patients

    Seq Age Sex Outcome Treatment
    1 Other