BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLE

    MDR report key: 15844434 · Received November 22, 2022

    Report

    Report Number
    2243072-2022-02025
    Event Type
    Malfunction
    Date Received
    November 22, 2022
    Date of Event
    October 31, 2022
    Report Date
    May 16, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER PHONE#: UNKNOWN. INITIAL REPORTER E-MAIL: UNKNOWN. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6), USA HAS BEEN USED AS A DEFAULT. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D1: MEDICAL DEVICE BRAND NAME- BD NANO¿ 2ND GEN PEN NEEDLE. D3: MEDICAL DEVICE MANUFACTURER -BECTON DICKINSON AND CO. D4 UDI: (B)(4). D4. MEDICAL DEVICE LOT #: 1351564. D4. MEDICAL DEVICE EXPIRATION DATE: 31DEC2026. H4. DEVICE MANUFACTURE DATE: 17DEC2021. D4. MEDICAL DEVICE LOT #: 1350732. D4. MEDICAL DEVICE EXPIRATION DATE: 31DEC2026. H4. DEVICE MANUFACTURE DATE: 16DEC2021. G1: MANUFACTURING LOCATION BECTON DICKINSON AND CO. G5: PMA/510(K)# K212015. D9: DEVICE AVAILABLE FOR EVAL YES. D9: RETURNED TO MANUFACTURER ON: 03JAN2023. H.6. INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 2ND COMPLAINT FOR THE REPORTED LOT NUMBER1351564 AND THE 4TH COMPLAINT FOR THE REPORTED LOT NUMBER 1350732 . 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. HENCE A POTENTIAL ROOT CAUSE CANNOT BE DETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD NANO¿ 4MM PEN NEEDLE HAD NO INSULIN FLOW DURING THE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER STATED, NO INSULIN FLOW WHEN TAKING INJECTION STATED, HE DOES NOT PRIME PEN NEEDLE BEFORE TAKING INJECTION BUT HE WILL GOING FORWARD.".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NANO¿ 2ND GEN PEN NEEDLE HAD NO INSULIN FLOW DURING THE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER STATED, NO INSULIN FLOW WHEN TAKING INJECTION STATED, HE DOES NOT PRIME PEN NEEDLE BEFORE TAKING INJECTION BUT HE WILL GOING FORWARD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1725647 BD NANO¿ 2ND GEN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown