BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 18220399 · Received November 28, 2023

    Report

    Report Number
    1710034-2023-01343
    Event Type
    Malfunction
    Date Received
    November 28, 2023
    Date of Event
    October 31, 2023
    Report Date
    May 20, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    K952861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS (UPDATED SINCE LAST FOLLOW UP AS A PHYSICAL SAMPLE WAS RECEIVED): RECEIVED 3 PHOTOS AND ONE UNSEALED 22GA X 1.00IN. INSYTE AUTOGUARD UNIT FROM LOT #3032974. THE PHOTOGRAPHS SHOWED MULTIPLE SMALL SOLID BLACK SPECKS ON THE GRIP OF THE UNIT. THE REPORTED DEFECT WAS CONFIRMED. AS DESCRIBED WITH THE PREVIOUSLY INVESTIGATED PHOTO SAMPLES, THE DEFECT OBSERVED ON THE RETURNED UNIT WAS CONFIRMED TO BE BURNT RESIN EMBEDDED IN THE MOLDING. THE BURNT RESIN IS AN EMBEDDED NON-FOREIGN MATERIAL IN THE GRIP COMPONENT OF THE DEVICE AND NOT IN THE FLUID PATH. THE BLACK SPECKS ARE INTRODUCED DURING THE MOLDING PROCESS. DURING MOLDING, RESIN IS USED TO FORM THE DEVICE. IT¿S POSSIBLE THAT PREVIOUS RESIN GOT BURNT AND WAS STILL PRESENT WHEN THIS DEVICE WAS IN THE MOLDING PROCESS, CAUSING THE BLACK SOLID FOREIGN MATTER. QUALITY CONTROL PLAN VISUAL INSPECTION IS PERFORMED TO MITIGATE THE OCCURRENCE OF THIS DEFECT. A NOTIFICATION OF AWARENESS WAS SENT TO THE MOLDING DEPARTMENT TO COMMUNICATE THE OCCURRENCE OF THE DEFECT ON THIS LOT NUMBER. INVESTIGATION CONCLUSION(S): THE DEFECT OF ¿FOREIGN MATTER¿ WAS CONFIRMED. PROBABLE ROOT CAUSE(S): MANUFACTURING/MOLDING.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT OF DISCOLORATION ON THE DEVICE WAS CONFIRMED AND THE CAUSE APPEARED TO BE ATTRIBUTABLE TO THE MANUFACTURING PROCESS. THREE PHOTOGRAPHS WERE PROVIDED FOR INVESTIGATION, WHICH SHOWED A 22G INSYTE AUTOGUARD DEVICE. BLACK SPOTS WERE DISTRIBUTED THROUGHOUT THE GRIP, WHICH WAS CONSISTENT WITH BURNT RESIN THAT GETS EMBEDDED WITHIN THE MOLDED COMPONENT. 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. INVESTIGATION CONCLUSION(S): THE DEFECT OF ¿FOREIGN MATTER¿ WAS CONFIRMED. PROBABLE ROOT CAUSE(S): MANUFACTURING/MOLDING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD HAS FOREIGN MATTER UNDER THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INSYTE #22 HAS IT SHIELD REMOVED AND SHOWS STAINS INSIDE THE SYSTEM.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536868 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3032974 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown