BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)

    MDR report key: 18007875 · Received October 25, 2023

    Report

    Report Number
    9616656-2023-01140
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    October 20, 2023
    Report Date
    November 16, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K182320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. H.3. 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¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) THERE WERE ISSUES PRIMING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NO INSULIN FLOW WHEN TAKING INJECTION AND SOMETIMES WHEN PRIMING. LOT: 3032942. CATALOG: 320550. DATE OF EVENT: UNKNOWN. SAMPLES: NO.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM ((B)(4)) THERE WERE ISSUES PRIMING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NO INSULIN FLOW WHEN TAKING INJECTION AND SOMETIMES WHEN PRIMING. LOT: 3032942, CATALOG: 320550, DATE OF EVENT: UNKNOWN, SAMPLES: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1733764 BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 3032942 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown