BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD NANO¿ PRO ULTRA-FINE¿ PEN NEEDLES 32G X 4MM (100 COUNT)

    MDR report key: 16740447 · Received April 13, 2023

    Report

    Report Number
    9616656-2023-00359
    Event Type
    Injury
    Date Received
    April 13, 2023
    Date of Event
    March 23, 2023
    Report Date
    April 18, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205554
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NANO¿ PRO ULTRA-FINE¿ PEN NEEDLES 32G X 4MM (100 COUNT) THE MEDICATION WAS NOT PROPERLY DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED WHEN SHE TAKES INJECTION, SHE IS NOT ABSORBING THE MEDICATION BECAUSE HER NUMBERS ARE REALLY HIGH. STATED, SHE DEVELOPS A LARGE BUBBLE UNDERNEATH THE SKIN AND RASH. CONSUMER WANTS TO KNOW THE INGREDIANTS/MATERIAL USED IN PEN NEEDLES STATED, SHE IS WORKING CLOSELY WITH HER DOCTOR TO DETERMINE WHAT MIGHT BE BEST FOR INJECTION NEEDS. LOT: 2123095. CATALOG: 320555. DATE OF EVENT: UNKNOWN. SAMPLES: PENDING REPONSE FROM CONSUMER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NANO¿ PRO ULTRA-FINE¿ PEN NEEDLES 32G X 4MM (100 COUNT) THE MEDICATION WAS NOT PROPERLY DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED WHEN SHE TAKES INJECTION, SHE IS NOT ABSORBING THE MEDICATION BECAUSE HER NUMBERS ARE REALLY HIGH STATED, SHE DEVELOPS A LARGE BUBBLE UNDERNEATH THE SKIN AND RASH. CONSUMER WANTS TO KNOW THE INGREDIENTS/MATERIAL USED IN PEN NEEDLES STATED, SHE IS WORKING CLOSELY WITH HER DOCTOR TO DETERMINE WHAT MIGHT BE BEST FOR INJECTION NEEDS. LOT: 2123095, CATALOG: 320555, DATE OF EVENT: UNKNOWN, SAMPLES: PENDING RESPONSE FROM CONSUMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979006 BD NANO¿ PRO ULTRA-FINE¿ PEN NEEDLES 32G X 4MM (100 COUNT) HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2123095 00382903205554

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention