BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD BL 22GA X 1.0IN

    MDR report key: 11866741 · Received May 21, 2021

    Report

    Report Number
    1710034-2021-00428
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    April 21, 2021
    Report Date
    June 28, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: BD RECEIVED A 22 GAUGE INSYTE AUTOGUARD BLOOD CONTROL UNIT FROM LOT 0202583 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED THAT THE END OF THE BARREL WAS BROKEN WITH CRACKS RUNNING UP THE SIDES. BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THE OBSERVED DAMAGE WAS CAUSED BY A MISALIGNMENT WHILE LOADING OR SEATING THE BARREL DURING THE MANUFACTURING PROCESS. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. A NOTIFICATION WAS ISSUED BY THE MANUFACTURING FACILITY TO ALL MANUFACTURING PERSONNEL TO RAISE AWARENESS OF THIS INCIDENT. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSYTE AUTOGUARD BL 22GA X 1.0IN WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CHAMBER BROKEN.

    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 INSYTE AUTOGUARD BL 22GA X 1.0IN WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CHAMBER BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761945 INSYTE AUTOGUARD BL 22GA X 1.0IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381823 0202583 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1