BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿+ PRO PEN NEEDLE

    MDR report key: 15839435 · Received November 21, 2022

    Report

    Report Number
    9616656-2022-01269
    Event Type
    Malfunction
    Date Received
    November 21, 2022
    Date of Event
    October 31, 2022
    Report Date
    December 9, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205592
    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

    INITIAL REPORTER PHONE#: UNKNOWN. INITIAL REPORTER E-MAIL: UNKNOWN. 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

    H6: INVESTIGATION SUMMARY: TWO SEALED 32G X 4MM PEN NEEDLE CARTONS AND FIVE PHOTOS WERE RETURNED FROM LOT. NO. 2060475, CAT. NO. 320559. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES AND PHOTOS AND MISSING PRINT ON THE LID OF THE CARTON WAS OBSERVED. 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. ROOT CAUSE OF THIS ISSUE IS SUPPLIER RELATED AND WILL BE INVESTIGATED UNDER (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRODUCT NAMES ON 2 SHELF CARTONS OF BD MICRO-FINE¿+ PRO PEN NEEDLES WERE FADED AND ILLEGIBLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS IS A REPORT ABOUT A PRINTING ISSUE OF SHELF CARTONS. ACCORDING TO THE DISTRIBUTOR'S REPORT, THE PRINT WAS FADING AROUND THE AREA OF PRODUCT NAME ON THE SHELF CARTON SURFACES."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRODUCT NAMES ON 2 SHELF CARTONS OF BD MICRO-FINE¿+ PRO PEN NEEDLES WERE FADED AND ILLEGIBLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS IS A REPORT ABOUT A PRINTING ISSUE OF SHELF CARTONS. ACCORDING TO THE DISTRIBUTOR'S REPORT, THE PRINT WAS FADING AROUND THE AREA OF PRODUCT NAME ON THE SHELF CARTON SURFACES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2732430 BD MICRO-FINE¿+ PRO PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2060475 00382903205592

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown