BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17110964 · Received June 12, 2023

    Report

    Report Number
    9616656-2023-00575
    Event Type
    Malfunction
    Date Received
    June 12, 2023
    Date of Event
    May 19, 2023
    Report Date
    August 25, 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
    AZ, US
    Reporter Occupation
    003

    Narratives

    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.

    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. INVESTIGATION SUMMARY: CUSTOMER RETURNED 21 OPENED 32G 4MM PRO LOOSE PEN NEEDLES. IT WAS REPORTED BY THE CONSUMER THAT NEEDLE CLOG DURING INJECTION, STATED THAT THERE IS NO INSULIN FLOW. BLEEDING AT THE INJECTION SITE AFTER INJECTION. PAIN DURING INJECTION. ALL THE RETURNED SAMPLES VISUALLY INSPECTED AND OBSERVED 17 PEN NEEDLES WITH BENT NPE CANNULA AND 4 WITHOUT ANY DAMAGES. MOST LIKELY CLOG COULD HAVE OCCURRED DUE TO BENT NPE CANNULA. ROOT CAUSE FOR BENT NPE CANNULA CANNOT BE DETERMINED AS THE RETURN SAMPLES WERE OPEN. CLOG TEST HAS BEEN PERFORMED ON THE SAMPLE WITH NO DAMAGES AND OBSERVED NO ISSUES WITH FLOW. HENCE, EMBECTA WAS NOT ABLE TO CONFIRM THE ISSUE CLOG. 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. 0.0091 IN, 4. 0.0093 IN, 5. 0.0093 IN, 6. 0.0092 IN, 7. 0.0093 IN, 8. 0.0093 IN, 9. 0.0093 IN, 10. 0.0093 IN, 11. 0.0094 IN, 12. 0.0093 IN, 13. 0.0091 IN, 14. 0.0093 IN, 15. 0.0093 IN, 16. 0.0092 IN, 17. 0.0093 IN, 18. 0.0092 IN, 19. 0.0093 IN, 20. 0.0093 IN, 21. 0.0092 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 EACH NEEDLE POINT WAS INSPECTED, AND NO DEFECTS WERE FOUND. NO DEBRIS WAS FOUND AT THE TIP OF ANY OF THE NEEDLES. FLOUR WAS APPLIED TO THE NEEDLE'S CANNULAS TO ENSURE THAT LUBRICANT WAS PRESENT. SUFFICIENT LUBRICANT WAS FOUND ON ALL SAMPLES. HENCE, THE REPORTED ISSUE COULD NOT BE CONFIRMED. 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 SAMPLE RECEIVED, 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 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 NEEDLE CLOG DURING INJECTION, STATED THAT THERE IS NO INSULIN FLOW. BLEEDING AT THE INJECTION SITE AFTER INJECTION. PAIN DURING INJECTION. CONSUMER STATED THAT HER INJECTIONS ARE UNCOMFORTABLE BECAUSE SHE IS AFRAID OF NEEDLES. LOT #: 1160319. CATALOG #: 320550. DATE OF EVENT: UNKNOWN. SAMPLES: DISCARDED.

    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 NEEDLE CLOG DURING INJECTION, STATED THAT THERE IS NO INSULIN FLOW. BLEEDING AT THE INJECTION SITE AFTER INJECTION. PAIN DURING INJECTION. CONSUMER STATED THAT HER INJECTIONS ARE UNCOMFORTABLE BECAUSE SHE IS AFRAID OF NEEDLES. LOT #: 1160319. CATALOG #: 320550. DATE OF EVENT: UNKNOWN. SAMPLES: DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509625 BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 1160319 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown