BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY

    MDR report key: 11205890 · Received January 20, 2021

    Report

    Report Number
    9616656-2021-00053
    Event Type
    Malfunction
    Date Received
    January 20, 2021
    Date of Event
    January 4, 2021
    Report Date
    February 26, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201228
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY WAS DIFFICULT TO OPERATE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE PEN NEEDLE WILL NOT DIAL UP THE DOSE. THE BUTTON WILL NOT MOVE AND DOE SNOT PRESS DOWN THE DOSE. VERBATIM: CONSUMER REPORTED USING THE TROUJEO PEN WITH BD PEN NEEDLES. ISSUES WITH DIALING UP DOSE ON PEN . CONSUMER STATED DOES NOT MATTER IF BD NEEDLE IS ON THE PEN OR NOT. THE DOSE BUTTON WILL NOT MOVE TO DIAL UP THE DOSE. NOT PRESS DOWN THE DOSE. ADVISED CONSUMER TO CALL SANOFI PROVIDED PHONE # LOT #: 9183109. CATALOG#: 320883. DATE OF EVENT: (B)(6) 2021. SAMPLES = NO."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY WAS DIFFICULT TO OPERATE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE PEN NEEDLE WILL NOT DIAL UP THE DOSE. THE BUTTON WILL NOT MOVE AND DOE SNOT PRESS DOWN THE DOSE. VERBATIM: CONSUMER REPORTED USING THE TROUJEO PEN WITH BD PEN NEEDLES. ISSUES WITH DIALING UP DOSE ON PEN . CONSUMER STATED DOES NOT MATTER IF BD NEEDLE IS ON THE PEN OR NOT. THE DOSE BUTTON WILL NOT MOVE TO DIAL UP THE DOSE. NOT PRESS DOWN THE DOSE. ADVISED CONSUMER TO CALL SANOFI PROVIDED PHONE # LOT #: 9183109CATALOG#: 320883DATE OF EVENT: (B)(4) SAMPLES = NO"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101934 PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320122 9183109 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1