BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLICKFINE 32GX4MM DONGBAO 7ER

    MDR report key: 19927906 · Received August 7, 2024

    Report

    Report Number
    3002806818-2024-00019
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    May 30, 2024
    Report Date
    August 7, 2024
    Manufacturer
    YPSOMED AG
    Product Code
    FMI
    PMA / PMN Number
    K171984
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER COMPLETING AN INSULIN INJECTION AT HOME, THE PATIENT OBSERVED THAT IT WAS HIGHLY DIFFICULT TO DELIVER THE DRUG INTO THE BODY, THERE WAS DRUG LEAKAGE, AND THE INJECTION SITE REDNESS, SWELLING, AND PAIN. REVIEW OF PRODUCTION RECORDS SHOW NO ABNORMALITIES OR DEVIATIONS FROM THE VALIDATED MANUFACTURING PROCESS. THE NEEDLE TIP FROM THE CANNULA IS 100% CONTROLLED BEFORE THE INNER PROTECTIVE CAP IS FITTED. NO ANOMALIES WERE FOUND IN THE ADDITIONAL DOCUMENTS REVIEWED: BIOBURDEN, ENDOTOXIN LAL, CERTIFICATE OF IRRADIATION. PEN USED WITH THE NEEDLE WAS UNKNOWN AND THE DEVICE WAS NOT RETURNED. NO LEAKAGE WERE OBSERVED WHEN USED WITH COMPATIBLE PENS. PENETRATION TESTS WERE REVIEWED, AND NO ABNORMALITIES WERE FOUND. NO DEVICE ISSUES FOUND.

    Description of Event or Problem · 0

    AFTER COMPLETING AN INSULIN INJECTION AT HOME, THE PATIENT OBSERVED THAT IT WAS HIGHLY DIFFICULT TO DELIVER THE DRUG INTO THE BODY, THERE WAS DRUG LEAKAGE, AND THE INJECTION SITE REDNESS, SWELLING, AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573557 CLICKFINE 32GX4MM DONGBAO 7ER PEN NEEDLE FMI YPSOMED AG CLICKFINE 32GX4MM DONGBAO 7ER 231190-02

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other