BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOLOG FLEXPEN

    MDR report key: 13175470 · Received January 6, 2022

    Report

    Report Number
    13175470
    Event Type
    Malfunction
    Date Received
    January 6, 2022
    Date of Event
    December 15, 2021
    Report Date
    December 20, 2021
    Manufacturer
    BECTON DICKINSON PEN LIMITED
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NURSING BROUGHT GLARGINE INSULIN PEN TO PHARMACY, NOTING THAT IT WAS DIFFICULT TO ADMINISTER INSULIN THROUGH. UPON INSPECTION, IT APPEARS THAT THE SYRINGE WAS COMPLETELY FULL AND NO INSULIN HAD BEEN ADMINISTERED OUT OF IT OVER THE PAST 4 DAYS (WAS DISPENSED AT 0941). THERE WAS WHAT IS PRESUMED TO BE A PIECE OF THE PEN NEEDLE STUCK IN THE SYRINGE HUB, WHICH WOULDN'T ALLOW INSULIN TO MOVE THROUGH BUT WOULD ALLOW THE SYRINGE TO BE DEPRESSED. PHARMACY DISPOSED OF THE SYRINGE AND SENT A NEW ONE TO NURSE. LANTUS LOT: 1F7979A, NEEDLE LOT: 1134014. SANOFI MAKES THE INSULIN (LANTUS) AND THE PEN NEEDLE MANUFACTURER IS BD. NO PATIENT HARM, GLUCOSE SLIGHTLY ELEVATED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31862 NOVOLOG FLEXPEN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON PEN LIMITED 1134014

    Patients

    Seq Age Sex Outcome Treatment
    1 21535 DA Female