BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)

    MDR report key: 17199053 · Received June 26, 2023

    Report

    Report Number
    9616656-2023-00635
    Event Type
    Malfunction
    Date Received
    June 26, 2023
    Date of Event
    May 31, 2023
    Report Date
    August 24, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K212015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 30-JUN-2023. H6: INVESTIGATION SUMMARY: THE CUSTOMER RETURNED (3) OPEN 32G 4MM PEN NEEDLES FROM LOT#2012567, REPORTING NEEDLE CLOG. THE PEN NEEDLES WERE VISUALLY INSPECTED AND OBSERVED BROKEN CANNULA NPE ON ALL THE RETURNED PEN NEEDLES. MOST LIKELY THE CUSTOMER'S COMPLAINT REPORTED FAILURE OCCURRED DUE TO A BROKEN NPE CANNULA. AS THE RETURN SAMPLES WERE OPENED, THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE SAMPLE RETURNED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER-INDICATED FAILURE AS BROKEN CANNULA NPE. 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 WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER-INDICATED FAILURE AS BROKEN CANNULA NPE. THE ROOT CAUSE CANNOT BE DETERMINED, AS THE RETURNED SAMPLES WERE OPENED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) THE MEDICATION COULD NOT BE DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED, WHEN TAKING INJECTION, NO INSULIN FLOWS. STATED, SHE DOES PRIME. LOT: 2012567. CATALOG: 320550. DATE OF EVENT: UNKNOWN. SAMPLES: YES CL.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) THE MEDICATION COULD NOT BE DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED, WHEN TAKING INJECTION, NO INSULIN FLOWS. STATED, SHE DOES PRIME. LOT: 2012567. CATALOG: 320550. DATE OF EVENT: UNKNOWN. SAMPLES: YES CL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930242 BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 2012567 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown