BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLES

    MDR report key: 15225660 · Received August 15, 2022

    Report

    Report Number
    9616656-2022-00855
    Event Type
    Malfunction
    Date Received
    August 15, 2022
    Date of Event
    July 19, 2022
    Report Date
    September 26, 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
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 01-AUG-2022. INVESTIGATION SUMMARY: CUSTOMER RETURNED (35) UNOPENED 32GX4MM BD PEN NEEDLES FROM LOT# 1173074. THE CUSTOMER REPORTED THAT THE PATIENT END BENDS WHEN TAKING INJECTION, THE PATIENT END IS BROKEN AFTER INJECTION, AND THAT THE THUMB PRESS/BUTTON IS HARD TO PUSH DURING INJECTION. 30 OUT OF THE 35 RETURNED PEN NEEDLES WERE EXAMINED, AND TESTED FOR VISUAL INSPECTION OF POINT GEOMETRY, OUTER DIAMETER AND LUBE COVERAGE. ALL OBSERVATIONS FELL WITHIN SPECIFICATION. NEXT, ALL 30 SAMPLES WERE THEN TESTED FOR FLOW USING A TEST PEN INJECTOR: ALL 30 PEN NEEDLES WERE ABLE TO EXPEL PROPERLY. NO EVIDENCE OF PATIENT END OR PEN NEEDLE OPERATED DEFECTS WERE OBSERVED ON THE TESTED SAMPLES. THE ALLEGED ISSUES COULD NOT BE CONFIRMED BASED ON THE SAMPLES RETURNED FOR 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. EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING 30 BD NANO¿ 2ND GEN PEN NEEDLES THAT WHEN TAKING INJECTION IT'S HARD PUSHING ON THE DOSE BUTTON. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED, WHEN TAKING INJECTION, HE HAS TO PUSH HARD ON "THUMB PRESS/BUTTON.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING 30 BD NANO¿ 2ND GEN PEN NEEDLES THAT WHEN TAKING INJECTION IT'S HARD PUSHING ON THE DOSE BUTTON. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED, WHEN TAKING INJECTION, HE HAS TO PUSH HARD ON "THUMB PRESS/BUTTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1987690 BD NANO¿ 2ND GEN PEN NEEDLES NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON AND CO. 320550 1173074 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown