BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD¿ PEN NEEDLE

    MDR report key: 18167180 · Received November 19, 2023

    Report

    Report Number
    2243072-2023-02056
    Event Type
    Malfunction
    Date Received
    November 19, 2023
    Date of Event
    October 27, 2023
    Report Date
    November 29, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    NA
    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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: CORRECTION: AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 9260748 WAS SENT IN ERROR. COMPLAINT CAPTURED UNDER REPORT (B)(4) MFR#2243072-2023-02027. MFR#: 2243072-2023-02056 IS VOID AS A RESULT.

    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, 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. E.1. THE CUSTOMER'S ADDRESS IS UNKNOWN. NEW JERSEY, USA HAS BEEN USED AS A DEFAULT. H.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 WHILE USING THE UNSPECIFIED BD¿ PEN NEEDLE IT WAS DIFFICULT/UNABLE TO OPERATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE UNSPECIFIED BD¿ PEN NEEDLE IT WAS DIFFICULT/UNABLE TO OPERATE¿ THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DIFFICULT/UNABLE TO OPERATE¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917715 UNSPECIFIED BD¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown