BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)

    MDR report key: 16924808 · Received May 12, 2023

    Report

    Report Number
    9616656-2023-00484
    Event Type
    Malfunction
    Date Received
    May 12, 2023
    Date of Event
    April 21, 2023
    Report Date
    August 3, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K182320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. 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

    H6: INVESTIGATION SUMMARY A COMPLAINT LOT HISTORY CHECK WAS PERFORMED ON LOT # 2012567 FOR NEEDLE CLOG. THIS IS THE 1ST. RELATED COMPLAINT FOR NEEDLE CLOG ON LOT # 2012567. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR THE UNKNOWN LOT#, 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 CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: - UNCONFIRMED: EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED TO BD PEN NEEDLE DON'T ALLOW INSULIN FLOW. CONSUMER REPORTED AFTER INJECTING THE NEEDLE IN ARM SITE AND HOLDING IN SITE FOR 10-15 SECONDS, THEN REMOVE NEEDLE FROM SITE, NOTICES INSULIN DROPS COME OUT OF THE NEEDLE. CALLER INFORMED DOES NOT COMPLETE A FLOW CHECK. HE REUSES THE NEEDLES AND STORES THE NEEDLE ON HIS PEN. INFORMED CALLER OF PROPER USE OF PEN NEEDLES. DATE OF EVENT 04/21/2023 = 1 PEN NEEDLES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED TO BD PEN NEEDLE DON'T ALLOW INSULIN FLOW. CONSUMER REPORTED AFTER INJECTING THE NEEDLE IN ARM SITE AND HOLDING IN SITE FOR 10-15 SECONDS, THEN REMOVE NEEDLE FROM SITE, NOTICES INSULIN DROPS COME OUT OF THE NEEDLE. CALLER INFORMED DOES NOT COMPLETE A FLOW CHECK. HE REUSES THE NEEDLES AND STORES THE NEEDLE ON HIS PEN. INFORMED CALLER OF PROPER USE OF PEN NEEDLES. DATE OF EVENT (B)(6) 2023 = 1 PEN NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1184616 BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 2012567 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown