BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD MICRO-FINE¿+ PEN NEEDLES

    MDR report key: 16678323 · Received April 4, 2023

    Report

    Report Number
    3014704491-2023-00093
    Event Type
    Injury
    Date Received
    April 4, 2023
    Date of Event
    March 6, 2023
    Report Date
    April 20, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FMI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. DHR WAS REVIEWED AND THERE WERE NOT ANY QNS OR OTHER EVENTS THAT COULD BE RELATED TO THIS COMPLAINT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICRO-FINE¿+ PEN NEEDLES EXPERIENCED CANNULA BREAK OFF UNDER THE PATIEN SKIN. UNEXPECTED MEDICAL INTERVENTION WAS PERFORMED TO REMOVE THE NEEDLE IN PATIENT ARM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON THE MORNING OF (B)(6) 2023, THE PEN NEEDLE OF THE DISPOSABLE INJECTION NEEDLE ACCIDENTALLY BROKE UNDER THE SKIN WHEN THE NEEDLE WAS USED BY THE PATIENT. THE PATIENT WENT TO THE HOSPITAL IMMEDIATELY, AND TOOK IT OUT AFTER DISINFECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICRO-FINE¿+ PEN NEEDLES EXPERIENCED CANNULA BREAK OFF UNDER THE PATIENT SKIN. UNEXPECTED MEDICAL INTERVENTION WAS PERFORMED TO REMOVE THE NEEDLE IN PATIENT ARM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON THE MORNING OF (B)(6) 2023, THE PEN NEEDLE OF THE DISPOSABLE INJECTION NEEDLE ACCIDENTALLY BROKE UNDER THE SKIN WHEN THE NEEDLE WAS USED BY THE PATIENT. THE PATIENT WENT TO THE HOSPITAL IMMEDIATELY AND TOOK IT OUT AFTER DISINFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383874 BD MICRO-FINE¿+ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 2040499

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention