BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ ULTRA FINE¿ PEN NEEDLE

    MDR report key: 16710193 · Received April 10, 2023

    Report

    Report Number
    9616656-2023-00342
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    Date of Event
    March 23, 2023
    Report Date
    May 4, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201228
    PMA / PMN Number
    K213478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2083029 MEDICAL DEVICE EXPIRATION DATE: 30-APR-2027 DEVICE MANUFACTURE DATE: 17-JUN-2022 MEDICAL DEVICE LOT #: 2048904 MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2027 DEVICE MANUFACTURE DATE: 06-MAY-2022 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 AN UNSPECIFIED NUMBER OF BD NANO¿ ULTRA FINE¿ PEN NEEDLES FROM LOTS 2083029 AND 2048904 HAD NO INSULIN FLOW DURING THE INJECTION AND PRIMING PROCESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED, "CLOGGED PEN NEEDLES". CONSUMER REPORTED NO INSULIN FLOW WHEN TAKING INJECTION STATED, NO INSULIN FLOW WHEN PRIMING. STATED, ITS HAPPENED WITH MORE THAN ONE BOX.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD NANO¿ ULTRA FINE¿ PEN NEEDLES FROM LOTS 2083029 AND 2048904 HAD NO INSULIN FLOW DURING THE INJECTION AND PRIMING PROCESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED, "CLOGGED PEN NEEDLES".CONSUMER REPORTED NO INSULIN FLOW WHEN TAKING INJECTION STATED, NO INSULIN FLOW WHEN PRIMING STATED, ITS HAPPENED WITH MORE THAN ONE BOX"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911547 BD NANO¿ ULTRA FINE¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320122 SEE H10 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown