BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLICKFINE 32GX4MM DONGBAO 7CT

    MDR report key: 17980445 · Received October 20, 2023

    Report

    Report Number
    3002806818-2023-00019
    Event Type
    Injury
    Date Received
    October 20, 2023
    Date of Event
    August 24, 2023
    Report Date
    October 20, 2023
    Manufacturer
    YPSOMED AG
    Product Code
    FMI
    PMA / PMN Number
    K171984
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE NURSE'S FINGER BLED WHEN IT WAS PUNCTURED WHILE TAKING OFF THE OUTER PROTECTIVE CAP OF THE CLICKFINE DURING AN INSULIN INJECTION WITH A NOVOPEN. THE CANNULA WAS FOUND BENT AND STRETCHED OUT OF THE NEEDLE HUB. REVIEW OF MANUFACTURING DOCUMENTATION SHOWED NO ABNORMALITIES OR DEVIATIONS FROM THE VALIDATED MANUFACTURING PROCESS FOR THE MAIN BATCH 221515. ASSEMBLY ROCESS REVIEW OF THE STRAIGHTNESS CHECK FOR THE CANNULA IS FOUND TO BE 100% CONTROLLED BEFORE THE INNER PROTECTIVE CAP IS FITTED. NON-CONFORMING PARTS WERE AUTOMATICALLY SORTED OUT AS EXPECTED.

    Description of Event or Problem · 0

    THE NURSE'S FINGER BLED WHEN IT WAS PUNCTURED WHILE TAKING OFF THE OUTER PROTECTIVE CAP OF THE CLICKFINE DURING AN INSULIN INJECTION WITH A NOVOPEN. THE CANNULA WAS FOUND BENT AND STRETCHED OUT OF THE NEEDLE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120830 CLICKFINE 32GX4MM DONGBAO 7CT PEN NEEDLE FMI YPSOMED AG CLICKFINE 32GX4MM DONGBAO 7CT 221515-02

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other