BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLICKFINE 32GX4MM DONGBAO 7ER

    MDR report key: 21091831 · Received January 7, 2025

    Report

    Report Number
    3002806818-2025-00001
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    November 3, 2024
    Report Date
    January 7, 2025
    Manufacturer
    YPSOMED AG
    Product Code
    FMI
    PMA / PMN Number
    K171984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT FELT INTENSE PAIN AFTER COMPLETING AN INSULIN INJECTION. THE PEN COULD NOT PUSH IN THE NEEDLE. THE NEEDLE WAS FOUND TO BE BLOCKED AND BENT. THE PREVIOUS INJECTION FROM THE SAME DAY HAD NO ISSUES. REVIEW OF PRODUCTION DOCUMENTS REVEALED NO ABNORMALITIES OR DEVIATIONS FROM THE VALIDATED MANUFACTURING PROCESSES FOR THE BATCH. IN-PROCESS CONTROL FOR THE NEEDLE TIP TO THE CANNULA IS 100% COMPLETED BEFORE THE INNER PROTECTIVE CAP IS FITTED. IN-PROCESS PERMEABILITY TEST WAS ALSO 100% REVIEWED AFTER SILICONIZATION. NO DEVICE PROBLEM COULD BE FOUND.

    Description of Event or Problem · 0

    THE PATIENT FELT INTENSE PAIN AFTER COMPLETING AN INSULIN INJECTION. THE PEN COULD NOT PUSH IN THE NEEDLE. THE NEEDLE WAS FOUND TO BE BLOCKED AND BENT. THE PREVIOUS INJECTION FROM THE SAME DAY HAD NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834411 CLICKFINE 32GX4MM DONGBAO 7ER PEN NEEDLES FMI YPSOMED AG CLICKFINE 32GX4MM DONGBAO 7ER 231190-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown