BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD PNK 20GA X 1.16IN

    MDR report key: 18869085 · Received March 8, 2024

    Report

    Report Number
    1710034-2024-00168
    Event Type
    Malfunction
    Date Received
    March 8, 2024
    Date of Event
    February 8, 2024
    Report Date
    April 29, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814343
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: RECEIVED ONE UNSEALED 20GA X 1.16IN. INSYTE AUTOGUARD UNIT FROM LOT: 3251084. ADDITIONALLY, 4 PHOTOS WERE PROVIDED. THE PHOTOS PROVIDED DO NOT DISPLAY THE SAME DEFECT THAT WAS DISCOVERED IN THIS INVESTIGATION. THE PHOTOS ALSO SHOW DIFFERENT LOT NUMBERS THAN FROM THE UNIT THAT WAS PHYSICALLY PROVIDED. VISUAL INSPECTION OF THE PHYSICAL SAMPLE DISCOVERED THAT THE UNIT WAS UNSEALED AND USED. THE BUTTON WAS UNABLE TO BE ACTIVATED. MICROSCOPIC ANALYSIS DISCOVERED THAT THERE WAS ADHESIVE THAT FLOWED BETWEEN THE NEEDLE HUB AND THE GRIP. THIS MAY POUR BETWEEN THE BUTTON AND PREVENT ANY BUTTON ACTIVATION OR NEEDLE RETRACTION. THE REPORTED DEFECT WAS CONFIRMED. DURING MANUFACTURING, ADHESIVE IS DISPENSED INTO THE HUB TO SECURE THE CANNULA. STATION MISALIGNMENT MAY CAUSE THE ADHESIVE TO POUR ON THE OUTSIDE OF THE HUB WHICH CAN THEN FLOW IN BETWEEN THE NEEDLE HUB AND THE GRIP OR THE BUTTON. THIS MAY CAUSE PARTIAL/SLOW/ OR NO RETRACTION. A VISION SYSTEM SOFTWARE IS IN PLACE TO MITIGATE THE OCCURRENCE OF THIS DEFECT. THE APPROPRIATE MANUFACTURING PERSONNEL WERE NOTIFIED OF THIS COMPLAINT. 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. A TREND WAS IDENTIFIED FOR NEEDLE RETRACTION FAILURE COMPLAINTS AND A CAPA WAS OPENED TO ADDRESS THIS ISSUE. THE IMPLICATED LOT WAS MANUFACTURED AFTER THE IMPLEMENTATION OF THE CORRECTIVE ACTIONS. THIS COMPLAINT TYPE AND CORRECTIVE ACTION WILL CONTINUE TO BE MONITORED FOR EFFECTIVENESS. INVESTIGATION CONCLUSION(S): THE DEFECT OF ¿NEEDLE RETRACTION FAILURE¿ WAS CONFIRMED. PROBABLE ROOT CAUSE(S): MANUFACTURING.

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    "IT WAS REPORTED THAT TWO BD INSYTE AUTOGUARD PNK 20GA X 1.16IN NEEDLES' DID NOT FULLY RETRACT THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE¿RE SEEING A PATTERN WITH THE SAFETY MECHANISM ON THE 20GA INSYTE AUTOGUARDS' NOT COMPLETELY COVERING THE END OF THE SHARP AFTER DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681418 BD INSYTE AUTOGUARD PNK 20GA X 1.16IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3251084 00382903814343

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown