BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ PRO PEN NEEDLE

    MDR report key: 16713485 · Received April 11, 2023

    Report

    Report Number
    9616656-2023-00347
    Event Type
    Malfunction
    Date Received
    April 11, 2023
    Date of Event
    March 20, 2023
    Report Date
    April 27, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: ONE OPEN 32G X 4MM PEN NEEDLE SAMPLE AND THREE PHOTOS WERE RETURNED FROM LOT. NO. 2110717, CAT. NO. 320559. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND PHOTOS AND BLACK MARKS WERE OBSERVED ON THE COVER. 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. BLACK MARKS OCCURRED DUE TO THE MOULDING PRESS STOPPING WHILST HEATS REMAINED ON THE INJECTION UNIT.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT INK-LIKE FOREIGN MATTER WAS FOUND ON THE NON-PATIENT END OF THE BD MICRO-FINE¿ PRO PEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "ACCORDING TO THE USER'S VERBATIM REPORT, WHEN OPENING THE TEAR DROP LABEL, THERE WAS SOMETHING LIKE A INK ON THE NEEDLE NPE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INK-LIKE FOREIGN MATTER WAS FOUND ON THE NON-PATIENT END OF THE BD MICRO-FINE¿ PRO PEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "ACCORDING TO THE USER'S VERBATIM REPORT, WHEN OPENING THE TEAR DROP LABEL, THERE WAS SOMETHING LIKE A INK ON THE NEEDLE NPE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402257 BD MICRO-FINE¿ PRO PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2110717

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown