BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLE

    MDR report key: 17579935 · Received August 18, 2023

    Report

    Report Number
    9616656-2023-00918
    Event Type
    Injury
    Date Received
    August 18, 2023
    Date of Event
    August 7, 2023
    Report Date
    October 19, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K212015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. 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: 08-SEP-2023. . H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (8) UNOPENED 32G 4MM PEN NEEDLES FROM THE LOT# 2172135. IT WAS REPORTED BY THE CONSUMER THAT SOME OF THE PEN NEEDLES ARE "DULL". CONSUMER STATED, THE INJECTIONS WITH SOME PEN NEEDLES ARE "PAINFUL" THE RETURNED SAMPLES VISUALLY EXAMINED AND OBSERVED NO ISSUES. THE RETURNED SAMPLES WERE INSPECTED TO ENSURE THAT USING THEM WAS AS LEAST HARMFUL AS INTENDED. THE OUTER DIAMETERS OF THESE NEEDLES WERE MEASURED, THE RESULTS OF WHICH ARE FEATURED BELOW: 1. 0.0092 IN. 2. 0.0093 IN. 3. 0.0093 IN. 4. 0.0092 IN. 5. 0.0093 IN. 6. 0.0094 IN. 7. 0.0092 IN. 8. 0.0093 IN. ALL OF THE NEEDLES WERE MEASURED WITHIN ACCEPTABLE OUTER DIAMETERS FOR 32 GAUGE NEEDLES (0.0090 IN TO 0.0095 IN). THE INTEGRITY OF NEEDLE POINT WAS INSPECTED USING MAGNIFICATION AND NO DEFECTS WERE FOUND. NO DEBRIS WAS FOUND AT THE TIP OF THE NEEDLE. FLOUR WAS APPLIED TO THE NEEDLE'S CANNULAS TO ENSURE THAT LUBRICANT WAS PRESENT. SUFFICIENT LUBRICANT WAS FOUND ON ALL SAMPLES. NO DAMAGE TO THE NEEDLES OF ANY KIND WAS OBSERVED AND ALL FUNCTIONED AS INTENDED. 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. UNCONFIRMED: EMBECTA WAS NOT ABLE TO CONFIRM THE CUSTOMER INDICATED ISSUE. ROOT CAUSE CANNOT BE DETERMINED AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CONSUMER THAT WHILE USING THE BD NANO¿ 2ND GEN PEN NEEDLE SHE EXPERIENCED PAIN CAUSING INFECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED, THE INJECTIONS WITH SOME PEN NEEDLES ARE "PAINFUL" AND CAUSING AN "INFECTION" STATED, DID NOT SEEK MEDICAL.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CONSUMER THAT WHILE USING THE BD NANO¿ 2ND GEN PEN NEEDLE SHE EXPERIENCED PAIN CAUSING INFECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED, THE INJECTIONS WITH SOME PEN NEEDLES ARE "PAINFUL" AND CAUSING AN "INFECTION" STATED, DID NOT SEEK MEDICAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2167153 BD NANO¿ 2ND GEN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2172135 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention