BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLE

    MDR report key: 18248483 · Received December 1, 2023

    Report

    Report Number
    9616656-2023-01225
    Event Type
    Malfunction
    Date Received
    December 1, 2023
    Date of Event
    November 14, 2023
    Report Date
    January 4, 2024
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    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 3RD 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 THAT 15 OF THE BD NANO¿ 2ND GEN PEN NEEDLE WERE UNABLE TO DELIVER MEDICATION. REPORT 2 OF 2. THE FOLLOWING WAS RECIEVED FROM THE INITIAL REPORTER: CONSUMER REPORTED NO INSULIN FLOW WHEN PRIMING STATED, HE PRIMES 2 UNITS 30 PEN NEEDLES AFFECTED BETWEEN TWO LOT'S STATED, THE TWO LOT'S ARE MIXED IN AND HE CANNOT PROVIDE INFORMATION ON WHEN IT HAPPENED WITH WHICH LOT OR THE AMOUNT. LOT: 2130218, 3011419 CATALOG:320555 DATE OF EVENT: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 15 OF THE BD NANO¿ 2ND GEN PEN NEEDLE WERE UNABLE TO DELIVER MEDICATION. REPORT 2 OF 2. THE FOLLOWING WAS RECIEVED FROM THE INITIAL REPORTER: CONSUMER REPORTED NO INSULIN FLOW WHEN PRIMING STATED, HE PRIMES 2 UNITS 30 PEN NEEDLES AFFECTED BETWEEN TWO LOT'S STATED, THE TWO LOT'S ARE MIXED IN AND HE CANNOT PROVIDE INFORMATION ON WHEN IT HAPPENED WITH WHICH LOT OR THE AMOUNT. LOT: 2130218, 3011419. CATALOG:320555. DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504941 BD NANO¿ 2ND GEN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 3011419

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown