BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLES

    MDR report key: 14800368 · Received June 24, 2022

    Report

    Report Number
    9616656-2022-00664
    Event Type
    Malfunction
    Date Received
    June 24, 2022
    Date of Event
    May 26, 2022
    Report Date
    May 27, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K212015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 2ND. RELATED COMPLAINT FOR DOES NOT ATTACH AS INTENDED ON LOT # 1075773. A REVIEW OF RISK MANAGEMENT DOCUMENT (B)(4), REVISION 11, INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (NANO PRO PEN NEEDLE: DOES NOT ATTACH AS INTENDED) WAS CAPTURED AND ADDRESSED. INVESTIGATION SUMMARY: CUSTOMER RETURNED (13) OPEN 32GX4MM BD PEN NEEDLES WITHOUT TEAR DROP LABELS OR INNER SHIELDS ATTACHED. THE CUSTOMER REPORTED THAT THE NON-PATIENT END (NPE) WOULD NOT ATTACH TO THE INSULIN PEN PRIOR TO INJECTION. ALL 13 SAMPLES WERE EXAMINED, AND IT WAS OBSERVED THAT 11 PEN NEEDLES FEATURED A BENT NPE CANNULA AND 2 FEATURED A BROKEN NPE CANNULA. THE BENT AND BROKEN NPE CANNULAS WOULD PREVENT THE PEN NEEDLES FROM PROPERLY ATTACHING TO A PEN INJECTOR. SINCE ALL 13 SAMPLES WERE RETURNED AFTER USE, THE PROBABLE CAUSE OF THE BENT AND BROKEN NPE CANNULAS IS USER ERROR WHEN ATTACHING THE PEN NEEDLES TO A PEN INJECTOR. 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 AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (NPE CANNULA BENT, NPE CANNULA BROKEN) 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. THE ROOT CAUSE FOR THIS ISSUE IS USER RELATED. THE NPE CANNULAS WERE BENT OR BROKEN BY THE USER WHEN HANDLING THE PEN NEEDLES. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA/SA IS REQUIRED AT THIS TIME

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NANO¿ 2ND GEN PEN NEEDLES THAT THE NON PATIENT END WOULD NOT ATTACH TO INSULIN PEN PRIOR TO INJECTION ON 20 PEN NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NON PATIENT END WOULD NOT ATTACH TO INSULIN PEN PRIOR TO INJECTION. 20 PEN NEEDLES AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982985 BD NANO¿ 2ND GEN PEN NEEDLES NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON AND CO. 320550 1075773 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown