BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO FINE PLUS INSULIN PEN NEEDLE

    MDR report key: 11825041 · Received May 14, 2021

    Report

    Report Number
    9616656-2021-00525
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    April 14, 2021
    Report Date
    June 10, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY ONE OPEN 32G X 4MM PEN NEEDLE SAMPLE WITHOUT A TEARDROP LABEL AND THREE PHOTOS WERE RETURNED. AS NO TEARDROP LABEL WAS RETURNED IT CANNOT BE CONFIRMED AS TO WHICH LOT NUMBER THE SAMPLE WAS RETURNED FROM. VISUAL EXAMINATION WAS CARRIED OUT RETURNED SAMPLE AND PHOTOS AND EXCESSIVE LUBRICANT WAS OBSERVED ON THE NON PATIENT END OF THE CANNULA. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. THE ROOT CAUSE OF THIS ISSUE IS ADHESIVE SPLATTER FROM THE DISPENSE SYSTEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLACK DIRT WAS FOUND ON ABOUT 10 BD MICRO FINE PLUS¿ INSULIN PEN NEEDLES' TIPS. THE POSSIBLE LOTS THE EVENT OCCURRED IN INCLUDE 0119789, 0133282, AND 0133283. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "THIS IS A REPORT ABOUT FOREIGN MATTER (BLACK DIRT) ON THE NEEDLE NPE TIP FROM THE PATIENT THROUGH HIS/HER PHARMACY. ACCORDING TO THE PATIENT'S REPORT, A BLACK DIRT WAS OBSERVED ON THE NEEDLE NPE TIP IN ABOUT 10 OF 70 PRODUCTS. THE PATIENT BROUGHT ONLY ONE PEN NEEDLE TO THE PHARMACY, STATING THAT HE/SHE HAD DISCARDED THE OTHER PRODUCTS. THE PATIENT ALSO REPORTED THAT THE LOT NUMBER OF THE AFFECTED PRODUCTS IS ANY OF 0119789, 0133282, AND 0133283."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0119789. MEDICAL DEVICE EXPIRATION DATE: 2025-04-30. DEVICE MANUFACTURE DATE: 2020-04-28. MEDICAL DEVICE LOT #: 0133282. MEDICAL DEVICE EXPIRATION DATE: 2025-05-31. DEVICE MANUFACTURE DATE: 2020-05-12. MEDICAL DEVICE LOT #: 0133283. MEDICAL DEVICE EXPIRATION DATE: 2025-05-31. DEVICE MANUFACTURE DATE: 2020-05-12. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLACK DIRT WAS FOUND ON ABOUT 10 BD MICRO FINE PLUS¿ INSULIN PEN NEEDLES' TIPS. THE POSSIBLE LOTS THE EVENT OCCURRED IN INCLUDE 0119789, 0133282, AND 0133283. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "THIS IS A REPORT ABOUT FOREIGN MATTER (BLACK DIRT) ON THE NEEDLE NPE TIP FROM THE PATIENT THROUGH HIS/HER PHARMACY. ACCORDING TO THE PATIENT'S REPORT, A BLACK DIRT WAS OBSERVED ON THE NEEDLE NPE TIP IN ABOUT 10 OF 70 PRODUCTS. THE PATIENT BROUGHT ONLY ONE PEN NEEDLE TO THE PHARMACY, STATING THAT HE/SHE HAD DISCARDED THE OTHER PRODUCTS. THE PATIENT ALSO REPORTED THAT THE LOT NUMBER OF THE AFFECTED PRODUCTS IS ANY OF 0119789, 0133282, AND 0133283."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724829 BD MICRO FINE PLUS INSULIN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1