BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD¿ DUO

    MDR report key: 16324147 · Received February 8, 2023

    Report

    Report Number
    9616656-2023-00063
    Event Type
    Malfunction
    Date Received
    February 8, 2023
    Date of Event
    January 16, 2023
    Report Date
    March 8, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903296088
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 15-FEB-2023. INVESTIGATION SUMMARY TWENTY TWO SEALED 30G X 8MM AUTOSHIELD DUO PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 2040953, CAT. NO. 329608. A FUNCTIONALITY TEST AS PER Q-SOP-183-DL WAS CARRIED OUT ON ALL TWENTY TWO SAMPLES AND NO ISSUES WERE OBSERVED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    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

    IT WAS REPORTED WHILE USING BD AUTOSHIELD¿ DUO THE NEEDLES WERE NOT OPERATING CORRECTLY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CLAIMS THAT EVERY THIRD NEEDLE IS NOT WORKING.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD AUTOSHIELD¿ DUO THE NEEDLES WERE NOT OPERATING CORRECTLY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CLAIMS THAT EVERY THIRD NEEDLE IS NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2281524 BD AUTOSHIELD¿ DUO HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2040953 00382903296088

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown