BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿+ PRO PEN NEEDLE

    MDR report key: 16057080 · Received December 27, 2022

    Report

    Report Number
    9616656-2022-01415
    Event Type
    Malfunction
    Date Received
    December 27, 2022
    Date of Event
    December 8, 2022
    Report Date
    January 24, 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 THREE SEALED 32G X 4 MM PEN NEEDLE SAMPLES AND TWO PHOTOS WERE RETURNED FROM LOT. NO. 2082863, CAT. NO. 320559. A CLOG TEST AND A FUNCTIONALITY TEST WAS CARRIED OUT ON ALL THREE SAMPLES AND NO ISSUES WERE 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. NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED.

    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 LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: AND LEAKAGE ALSO OCCURRED (THE LEAKAGE SITE IS UNKNOWN).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICRO-FINE¿+ PRO PEN NEEDLE LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: AND LEAKAGE ALSO OCCURRED (THE LEAKAGE SITE IS UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2108873 BD MICRO-FINE¿+ PRO PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2082863

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown