BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18007776 · Received October 25, 2023

    Report

    Report Number
    1920898-2023-00737
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    October 19, 2023
    Report Date
    January 11, 2024
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K212015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. THIS IS THE 2ND 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES. D9: RETURNED TO MANUFACTURER ON: 01-DEC-2023. G.5.: 510 K UPDATED TO K212015 FROM K182320. H.6. INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 2ND 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. EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. E.1. ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED, THEREFORE, NJ WAS USED AS A PLACE HOLDER. 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) THE MEDICATION COULD NOT PROPERLY BE DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECEIVED VOICEMAIL FROM CONSUMER STATING SHE IS HAVING PROBLEM WITH NEEDLES. RETURNED CALL AND LEFT MESSAGE FOR CONSUMER TO CALL IN REGARDING PRODUCT COMPLAINT. CL FROM PHONE CALL ON 2023-10-20 21:30:43: CONSUMER STATED WHEN TAKING INJECTION, NO INSULIN FLOWS. STATED, AT LEAST 25% OF THE PEN NEEDLES IN BOX WILL NOT RELEASE INSULIN. STATED, SHE'S EXPERIENCED THE PROBLEM WITH PREVIOUS BOXES STATED, DOES NOT PRIME BEFORE INJECTION STATED, PREFERS ORIGINAL NANO PEN NEEDLES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) THE MEDICATION COULD NOT PROPERLY BE DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECEIVED VOICEMAIL FROM CONSUMER STATING SHE IS HAVING PROBLEM WITH NEEDLES. RETURNED CALL AND LEFT MESSAGE FOR CONSUMER TO CALL IN REGARDING PRODUCT COMPLAINT. FROM PHONE CALL ON (B)(6) 2023: CONSUMER STATED WHEN TAKING INJECTION, NO INSULIN FLOWS. STATED, AT LEAST 25% OF THE PEN NEEDLES IN BOX WILL NOT RELEASE INSULIN. STATED, SHE'S EXPERIENCED THE PROBLEM WITH PREVIOUS BOXES. STATED, DOES NOT PRIME BEFORE INJECTION. STATED, PREFERS ORIGINAL NANO PEN NEEDLES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) THE MEDICATION COULD NOT PROPERLY BE DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECEIVED VOICEMAIL FROM CONSUMER STATING SHE IS HAVING PROBLEM WITH NEEDLES. RETURNED CALL AND LEFT MESSAGE FOR CONSUMER TO CALL IN REGARDING PRODUCT COMPLAINT. CL. FROM PHONE CALL ON 2023-10-20 21:30:43: CONSUMER STATED WHEN TAKING INJECTION, NO INSULIN FLOWS. STATED, AT LEAST 25% OF THE PEN NEEDLES IN BOX WILL NOT RELEASE INSULIN. STATED, SHE'S EXPERIENCED THE PROBLEM WITH PREVIOUS BOXES. STATED, DOES NOT PRIME BEFORE INJECTION. STATED, PREFERS ORIGINAL NANO PEN NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048853 BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2271099 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown