BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO 2ND GEN PEN NEEDLE

    MDR report key: 11813410 · Received May 12, 2021

    Report

    Report Number
    9616656-2021-00512
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Date of Event
    February 8, 2021
    Report Date
    May 11, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K182320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: CUSTOMER RETURNED (34) USED 32GX4MM BD PEN NEEDLES WITHOUT TEAR DROP LABELS OR INNER SHIELDS ATTACHED. CONSUMER REPORTED THAT THE NEEDLE IS MISSING FROM NON PATIENT END OF 42 NEEDLE HUBS. ALL 34 RETURNED SAMPLES WERE EXAMINED, AND THE FOLLOWING WAS OBSERVED: 10 EXHIBITED A BENT NON-PATIENT END (NPE) CANNULA. 16 EXHIBITED A BROKEN NPE CANNULA. 8 EXHIBITED A STRAIGHT NPE CANNULA. THE SAMPLES WITH BENT OR BROKEN NPE CANNULAS WOULD BE THE CAUSE FOR THE CUSTOMER THINKING THAT THE NPE CANNULAS WERE MISSING, AS REPORTED. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. SINCE ALL 34 SAMPLES WERE RETURNED AFTER USE, THE PROBABLE CAUSE OF THE BENT OR 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 CONFORMANCES 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: BD 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 DUE TO USER ERROR 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 · 1

    IT WAS REPORTED THAT 16 BD NANO¿ 2ND GEN PEN NEEDLES' NON-PATIENT END CANNULAS WERE BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "GRANDSON OF CONSUMER REPORTED THAT THE NEEDLE IS MISSING FROM NON PATIENT END OF 42 NEEDLE HUBS. CONSUMER REPORTED THE SAME ISSUE BACK IN (B)(6) 2020". VIA BD INVESTIGATION: "CUSTOMER RETURNED (34) USED 32GX4MM BD PEN NEEDLES WITHOUT TEAR DROP LABELS OR INNER SHIELDS ATTACHED. CONSUMER REPORTED THAT THE NEEDLE IS MISSING FROM NON PATIENT END OF 42 NEEDLE HUBS. ALL 34 RETURNED SAMPLES WERE EXAMINED, AND THE FOLLOWING WAS OBSERVED: 10 EXHIBITED A BENT NON-PATIENT END (NPE) CANNULA. 16 EXHIBITED A BROKEN NPE CANNULA. 8 EXHIBITED A STRAIGHT NPE CANNULA".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710811 BD NANO 2ND GEN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 0189494 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1