BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLICKFINE 32GX4MM DONGBAO 7ER

    MDR report key: 20917336 · Received December 12, 2024

    Report

    Report Number
    3002806818-2024-00028
    Event Type
    Injury
    Date Received
    December 12, 2024
    Date of Event
    October 8, 2024
    Report Date
    December 12, 2024
    Manufacturer
    YPSOMED AG
    Product Code
    FMI
    PMA / PMN Number
    K171984
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FIVE MINUTES, AFTER COMPLETING AN INJECTION. THE PATIENT REPORTED, PAIN AT THE INJECTION SITE AND PROCEEDED TO THE HOSPITAL. UPON INSPECTION, A REDNESS WAS OBSERVED, AT THE INJECTION SITE. THE SITE WAS CLEANED AND DISINFECTED. REVIEW OF MANUFACTURING SHOWED NO ABNORMALITIES OR DEVIATIONS, FROM THE VALIDATED MANUFACTURING PROCESS FOR THE MAIN BATCH. IN-PROCESS CONTROL FOR THE NEEDLE TIP TO THE CANNULA IS 100% COMPLETED BEFORE THE INNER PROTECTIVE CAP IS FITTED. REVIEW OF BIOBURDEN, ENDOTOXIN AND IRRADIATION DOCUMENTATION REVEALED NO DEVIATIONS. NO DEVICE PROBLEM COULD BE FOUND.

    Description of Event or Problem · 0

    FIVE MINUTES, AFTER COMPLETING AN INJECTION. THE PATIENT REPORTED, PAIN AT THE INJECTION SITE AND PROCEEDED TO THE HOSPITAL. UPON INSPECTION, A REDNESS WAS OBSERVED, AT THE INJECTION SITE. THE SITE WAS CLEANED AND DISINFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1858998 CLICKFINE 32GX4MM DONGBAO 7ER PEN NEEDLE FMI YPSOMED AG CLICKFINE 32GX4MM DONGBAO 7ER 231235-02

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown