BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLES 4MM X 32G

    MDR report key: 15222152 · Received August 12, 2022

    Report

    Report Number
    9616656-2022-00850
    Event Type
    Malfunction
    Date Received
    August 12, 2022
    Date of Event
    July 7, 2022
    Report Date
    August 31, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K182320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE LOT #: 1132267. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2026. DEVICE MANUFACTURE DATE: 12-MAY-2021. MEDICAL DEVICE LOT #: 0231157. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2022. DEVICE MANUFACTURE DATE: 18-AUG-2022. MEDICAL DEVICE LOT #: 0274095. MEDICAL DEVICE EXPIRATION DATE: 30-SEPT-2025. DEVICE MANUFACTURE DATE: 30-SEPT-2020.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY CUSTOMER RETURNED A TOTAL OF 7 USED 4MM, 32 GAUGE NANO PRO PEN NEEDLES, WITH 5 BEING FROM LOT 1300016 AND 2 BEING FROM LOT 1132267. THE REMAINING 33 SAMPLES RETURNED WERE UNOPENED AND FROM LOT 0274095. 30 OF THE RETURNED SAMPLES WERE INSPECTED TO ENSURE THAT USING THEM WAS AS LEAST HARMFUL AS INTENDED. THE PEN NEEDLES WERE VISUALLY INSPECTED PRIOR TO FUNCTIONAL TESTING. 6 OF THE 7 USED PEN NEEDLES WERE FOUND TO HAVE BENT NEEDLES ON THE NON-PATIENT SIDE OF THE HUB¿S NEEDLE CANNULA. THIS DAMAGE WOULD PREVENT TESTING FOR CLOGS SINCE THE NEEDLE CANNOT PROPERLY ATTACH TO THE PEN. AS A RESULT, THE PEN NEEDLES APPEAR TO BE CLOGGED DURING USE. BASED ON THE DAMAGE PRESENT, THE NEEDLES BENDING MAY HAVE OCCURRED ACCIDENTALLY WHILE THE USER WAS PREPARING THE PEN NEEDLE FOR USE, POTENTIALLY IF THE PEN WAS NOT PROPERLY ALIGNED WITH THE CANNULA. THE REMAINING SAMPLES WERE ATTACHED TO A TEST PEN FILLED WITH SALINE. SALINE WAS PUSHED THROUGH THE SYSTEM AND OUT THE DISTAL TIP OF THE REMAINING PEN NEEDLES. NO ISSUES WERE FOUND WITH THE REMAINING PEN NEEDLES. 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 RECEIVED, EMBECTA FOUND THAT 6 USED PEN NEEDLES HAD BECOME BENT ON THE NON-PATIENT SIDE. THIS DAMAGE COULD RESEMBLE THE NEEDLE BEING CLOGGED AS A RESULT OF INSULIN NOT PASSING THROUGH THE NEEDLE. THE ROOT CAUSE OF THE NEEDLES BENDING APPEARS TO BE ACCIDENTAL DAMAGE FROM STRESSES CAUSED BY THE USER DURING ROUTINE USE. THIS WOULD HAVE ALSO GIVEN THE IMPRESSION THAT THE NEEDLE WAS CLOGGED SINCE INSULIN WOULD BE UNABLE TO PASS THROUGH THE CANNULA. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD NANO¿ 2ND GEN PEN NEEDLES 4MM X 32G THAT THE NEEDLE WAS UNABLE TO DELIVER MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN INJECTING, THE PEN NEEDLE DOES NOT COMPLETE A FLOW CHECK AND THE DOSE PEN STOPS DURING INJECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD NANO¿ 2ND GEN PEN NEEDLES 4MM X 32G THAT THE NEEDLE WAS UNABLE TO DELIVER MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN INJECTING, THE PEN NEEDLE DOES NOT COMPLETE A FLOW CHECK AND THE DOSE PEN STOPS DURING INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1995113 BD NANO¿ 2ND GEN PEN NEEDLES 4MM X 32G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 SEE H10 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown