BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G

    MDR report key: 8729215 · Received June 24, 2019

    Report

    Report Number
    9616657-2019-00239
    Event Type
    Malfunction
    Date Received
    June 24, 2019
    Date of Event
    June 6, 2019
    Report Date
    August 21, 2019
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403928659
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: AN ADDITIONAL LOT WAS ADDED TO THE COMPLAINT. D.4. MEDICAL DEVICE LOT #: 7067904. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: 3/8/2017. H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED (27) 32G X 4MM BD PEN NEEDLES FROM LOT 8102586, AND (4) 32G X 4MM BD PEN NEEDLES FROM LOT 7067904. CONSUMER REPORTED ON A FEW OCCASIONS, HE WAS NOT ABLE TO REMOVE THE PEN NEEDLE FROM INSULIN PEN AFTER INJECTION. STATED THE OUTER COVER JUST KEEPS TURNING AND WILL NOT ATTACH TO HUB TO REMOVE PEN NEEDLE. ALL 31 RETURNED SAMPLES WERE EXAMINED, AND IT WAS OBSERVED THAT 7 SAMPLES FROM LOT 8102586 AND 4 SAMPLES FROM LOT 7067904 WERE USED: TEAR DROP LABELS WERE PARTIALLY REMOVED. ALL 31 SAMPLES WERE TESTED FOR ATTACHMENT AND DETACHMENT USING A THREADED TEST FIXTURE, AND ALL 31 SAMPLES ATTACHED AND DETACHED FROM THE FIXTURE PROPERLY. AS NO MANUFACTURING DEFECTS WERE OBSERVED, THE ALLEGED ISSUES 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. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: -UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURES. 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE SECTION H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G EXPERIENCED AN INABILITY TO DETACH AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED ON A FEW OCCASIONS, HE WAS NOT ABLE TO REMOVE THE PEN NEEDLE FROM INSULIN PEN AFTER INJECTION. STATED THE OUTER COVER JUST KEEPS TURNING AND WILL NOT ATTACH TO HUB TO REMOVE PEN NEEDLE. STATED HE HAS TO SQUEEZE OUTER COVER REALLY TIGHT AND SOMETIMES, HE WAS FORCED TO REMOVE WITHOUT OUTER COVER RISKING A NEEDLE STICK. NO NEEDLE STICK OCCURRED. LOT: 8102586, ITEM: 320122, EXPIRATION DATE: 2023-04-30.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G EXPERIENCED AN INABILITY TO DETACH AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: CONSUMER REPORTED ON A FEW OCCASIONS, HE WAS NOT ABLE TO REMOVE THE PEN NEEDLE FROM INSULIN PEN AFTER INJECTION. STATED THE OUTER COVER JUST KEEPS TURNING AND WILL NOT ATTACH TO HUB TO REMOVE PEN NEEDLE. STATED HE HAS TO SQUEEZE OUTER COVER REALLY TIGHT AND SOMETIMES, HE WAS FORCED TO REMOVE WITHOUT OUTER COVER RISKING A NEEDLE STICK. NO NEEDLE STICK OCCURRED. LOT: 8102586, ITEM: 320122, EXPIRATION DATE: 2023-04-30.

    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 AN UNSPECIFIED NUMBER OF BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G EXPERIENCED AN INABILITY TO DETACH AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: CONSUMER REPORTED ON A FEW OCCASIONS, HE WAS NOT ABLE TO REMOVE THE PEN NEEDLE FROM INSULIN PEN AFTER INJECTION. STATED THE OUTER COVER JUST KEEPS TURNING AND WILL NOT ATTACH TO HUB TO REMOVE PEN NEEDLE. STATED HE HAS TO SQUEEZE OUTER COVER REALLY TIGHT AND SOMETIMES, HE WAS FORCED TO REMOVE WITHOUT OUTER COVER RISKING A NEEDLE STICK. NO NEEDLE STICK OCCURRED. LOT: 8102586, ITEM: 320122, EXPIRATION DATE: 04/30/2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523354 BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON AND CO. 7067904 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other