BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLES

    MDR report key: 18237369 · Received November 30, 2023

    Report

    Report Number
    9616656-2023-01217
    Event Type
    Malfunction
    Date Received
    November 30, 2023
    Date of Event
    November 20, 2023
    Report Date
    January 4, 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

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD NANO¿ 2ND GEN PEN NEEDLES 6 OF THE NEEDLES HAD NO INSULIN FLOW WHEN TAKING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NO INSULIN FLOW WHEN TAKING INJECTION. STATED, HE DISCOVERED AFTER REMOVING THE PEN NEEDLE, THE NON PATIENT END WAS BENT 6 PEN NEEDLES AFFECTED. DOES NOT PRIME BEFORE INJECTION. LOT: 3004043. CATALOG: 320550. DATE OF EVENT: UNKNOWN. SAMPLES: NO CL.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD NANO¿ 2ND GEN PEN NEEDLES 6 OF THE NEEDLES HAD NO INSULIN FLOW WHEN TAKING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NO INSULIN FLOW WHEN TAKING INJECTION STATED, HE DISCOVERED AFTER REMOVING THE PEN NEEDLE, THE NON PATIENT END WAS BENT 6 PEN NEEDLES AFFECTED. DOES NOT PRIME BEFORE INJECTION. LOT: 3004043. CATALOG: 320550. DATE OF EVENT: UNKNOWN. SAMPLES: NO CL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1884046 BD NANO¿ 2ND GEN PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 3004043 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown