BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE

    MDR report key: 9811938 · Received March 10, 2020

    Report

    Report Number
    9616656-2020-00203
    Event Type
    Malfunction
    Date Received
    March 10, 2020
    Date of Event
    February 19, 2020
    Report Date
    April 8, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY CUSTOMER RETURNED ONE (1) SEALED/UNUSED 30GX5MM BD AUTOSHIELD DUO PEN NEEDLE FROM LOT 9197048. CONSUMER REPORTED INSULIN PENS HAVE BEEN MALFUNCTIONING AND LEAKING WHEN INSULIN IS BEING DELIVERED. THE RETURNED PEN NEEDLE WAS EXAMINED, THEN TESTED FOR FLOW USING A TEST PEN INJECTOR: THE PEN NEEDLE WAS ABLE TO EXPEL PROPERLY. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. SINCE NO DEFECT WAS OBSERVED ON THE RETURNED SAMPLE FROM LOT 9197048, THE ALLEGED ISSUE COULD NOT BE CONFIRMED. FURTHERMORE, NO SAMPLES FROM LOT 9141961 WERE RETURNED, THEREFORE THE ISSUE COULD NOT BE CONFIRMED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. INVESTIGATION CONCLUSION BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. RATIONALE BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE SECTION H.10.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF 20 MARCH 2020 THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCE'S WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. INVESTIGATION CONCLUSION BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE PEN IS LEAKING WITH A BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED INSULIN PENS HAVE BEEN MALFUNCTIONING AND LEAKING WHEN INSULIN IS BEING DELIVERED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE PEN IS LEAKING WITH A BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED INSULIN PENS HAVE BEEN MALFUNCTIONING AND LEAKING WHEN INSULIN IS BEING DELIVERED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE PEN IS LEAKING WITH A BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED INSULIN PENS HAVE BEEN MALFUNCTIONING AND LEAKING WHEN INSULIN IS BEING DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278521 BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 9141961

    Patients

    Seq Age Sex Outcome Treatment
    1 Other