BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLICKFINE 32GX4MM DONGBAO 7ER

    MDR report key: 19278400 · Received May 9, 2024

    Report

    Report Number
    3002806818-2024-00013
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    March 21, 2024
    Report Date
    May 9, 2024
    Manufacturer
    YPSOMED AG
    Product Code
    FMI
    PMA / PMN Number
    K171984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT FOUND THAT THE TIP OF THE PEN NEEDLE SHE HAD PUCHASED FROM A PHARMACY HAD A BURR. THE PATIENT REPORTED THAT THE INJECTION WAS ABNORMALLY PAINFUL. THE PATIENT REPLACED THE NEEDLE TO COMPLETE THE INJECTION. THERE WERE NO ISSUES WIT HTHE NEW REPLACEMENT NEEDLE. REVIEW OF PRODUCTION RECORDS SHOWED NO ABNORMALITIES OR DEVIATIONS FROM VALIDATED MANUFACTURING PROCESS FOR THE MAIN BATCH 221319. IN-PROCESS CONTROL FOR THE NEEDLE TIP TO THE CANNULA IS 100% COMPLETED BEFORE THE INNER PROTECTIVE CAP IS FITTED. NO ISSUES COULD BE FOUND.

    Description of Event or Problem · 0

    THE PATIENT FOUND THAT THE TIP OF THE PEN NEEDLE SHE HAD PUCHASED FROM A PHARMACY HAD A BURR. THE PATIENT REPORTED THAT THE INJECTION WAS ABNORMALLY PAINFUL. THE PATIENT REPLACED THE NEEDLE TO COMPLETE THE INJECTION. THERE WERE NO ISSUES WIT HTHE NEW REPLACEMENT NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331061 CLICKFINE 32GX4MM DONGBAO 7ER PEN NEEDLE FMI YPSOMED AG CLICKFINE 32GX4MM DONGBAO 7ER 221319-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other