BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿+ PRO PEN NEEDLE

    MDR report key: 16067425 · Received December 29, 2022

    Report

    Report Number
    9616656-2022-01428
    Event Type
    Malfunction
    Date Received
    December 29, 2022
    Date of Event
    December 7, 2022
    Report Date
    January 20, 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 TWO OPEN 32 G X 4 MM PEN NEEDLE SAMPLES AND THREE PHOTOS WERE RETURNED FROM LOT. NO. 2060476, CAT. NO. 320559. A FUNCTIONALITY TEST WAS CARRIED OUT ON THE RETURNED SAMPLES AS PER Q-SOP-183-DL AND A LOOSE HUB IN COVER WAS OBSERVED ON ONE SAMPLE. NO ISSUES WERE OBSERVED WITH THE REMAINING SAMPLE. 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. THIS ISSUE WAS CAUSED BY AN INTERFERENCE FIT BETWEEN THE HUB AND THE COVER.

    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 THE BD MICRO-FINE¿+ PRO PEN NEEDLE WAS LOOSE, AND IT WAS DIFFICULT TO DETACH THE PEN NEEDLE FROM THE PEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE OUTER COVER WAS LOOSE, AND IT WAS DIFFICULT TO DETACH THE PEN NEEDLE FROM THE PEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICRO-FINE¿+ PRO PEN NEEDLE WAS LOOSE, AND IT WAS DIFFICULT TO DETACH THE PEN NEEDLE FROM THE PEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE OUTER COVER WAS LOOSE, AND IT WAS DIFFICULT TO DETACH THE PEN NEEDLE FROM THE PEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471448 BD MICRO-FINE¿+ PRO PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2060476

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown