BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD¿ PEN NEEDLE

    MDR report key: 18126520 · Received November 13, 2023

    Report

    Report Number
    2243072-2023-02029
    Event Type
    Malfunction
    Date Received
    November 13, 2023
    Date of Event
    November 8, 2023
    Report Date
    December 7, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: H.6. INVESTIGATION SUMMARY: AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 9222880 WAS SENT IN ERROR. CUSTOMER ADVISED THAT NO ISSUE WAS EXPERIENCED AND NO COMPLETED. MFR#: 2243072-2023-02029 IS VOID AS A RESULT.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND/OR LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWNH. 3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD¿ PEN NEEDLE LABEL WAS ILLEGIBLE. REPORT 2 OF 2. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CONSUMER REPORTED NEEDLE CLOG DURING INJECTION, STATED THAT THERE IS NO INSULIN FLOW. PACKAGING AND SAMPLES WERE DISCARDED, CONSUMER WAS NOT ABLE TO READ LOT # FROM THE TEAR DROP LABEL. SHE STATED THAT SHE IS USING NANO PEN NEEDLES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD¿ PEN NEEDLE LABEL WAS ILLEGIBLE. REPORT 2 OF 2. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CONSUMER REPORTED NEEDLE CLOG DURING INJECTION, STATED THAT THERE IS NO INSULIN FLOW. PACKAGING AND SAMPLES WERE DISCARDED, CONSUMER WAS NOT ABLE TO READ LOT # FROM THE TEAR DROP LABEL. SHE STATED THAT SHE IS USING NANO PEN NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1990976 UNSPECIFIED BD¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown