BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16916936 · Received May 11, 2023

    Report

    Report Number
    9616656-2023-00476
    Event Type
    Malfunction
    Date Received
    May 11, 2023
    Date of Event
    April 19, 2023
    Report Date
    August 17, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205554
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 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.

    Additional Manufacturer Narrative · 0

    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 COULD NOT BE DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING 2 PEN NEEDLES BENT NON PATIENT END AFTER PLACED ONTO HER PEN. CLOGGED FOR FLOW CHECK COULD NOT USE FOR INJECTION CONSUMER REPORTED 1 PEN NEEDLE STRAIGHT BUT CLOGGED DURING FLOW CHECK LOT # 2152813. CATALOG# 320555. DATE OF EVENT 04/19/2023 = 1 PEN NEEDLE - CLOGGED. DATE OF EVENT UNKNOWN OTHER DAY = 2 PEN NEEDLES BENT NON PATIENT END.

    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 COULD NOT BE DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING 2 PEN NEEDLES BENT NON PATIENT END AFTER PLACED ONTO HER PEN. CLOGGED FOR FLOW CHECK COULD NOT USE FOR INJECTION CONSUMER REPORTED 1 PEN NEEDLE STREIGHT BUT CLOGGED DURING FLOW CHECK. LOT # 2152813. CATALOG# 320555. DATE OF EVENT (B)(6) 2023 = 1 PEN NEEDLE - CLOGGED. DATE OF EVENT UNKNOWN OTHER DAY = 2 PEN NEEDLES BENT NON PATIENT END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032028 BD NANO¿ PRO ULTRA-FINE¿ PEN NEEDLES 32G X 4MM (100 COUNT) HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2152813 00382903205554

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown