BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLICKFINE 32GX4MM DONGBAO 7ER

    MDR report key: 20211206 · Received September 13, 2024

    Report

    Report Number
    3002806818-2024-00023
    Event Type
    Injury
    Date Received
    September 13, 2024
    Date of Event
    July 16, 2024
    Report Date
    September 13, 2024
    Manufacturer
    YPSOMED AG
    Product Code
    FMI
    PMA / PMN Number
    K171984
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING AN INSULIN INJECTION, THE PATIENT'S PUNCTURE SITE APPEARED HARD, RED, AND SWOLLEN. THE PATIENT EXPRESSED EMOTIONAL DISTRESS AND FELT PHYSICAL PAIN AND HEAT IN THE PUNCTURE SITE, AMONG OTHER ADVERSE REACTIONS. A SURGICAL CONSULTATION WAS REQUESTED. THE DOCTOR USED TDP IRRADIATION AND LOCAL ANTI-INFECTION TREATMENT TO ADDRESS THE ISSUE. A REVIEW FOR ANY INTERNAL DEVIATIONS DURING PRODUCTION SHOWED NO ABNORMALITIES OR DEVIATIONS FROM THE VALIDATED MANUFACTURING PROCESS. IN-PROCESS CONTROL FOR THE NEEDLE TIP TO THE CANNULA IS 100% COMPLETED BEFORE THE INNER PROTECTIVE CAP IS FITTED. A REVIEW OF BIOBURDEN, ENDOTOXIN LAL, AND IRRADIATION CERT SHOWED NO ANOMALIES. BIOCOMPATIBILITY TESTING COMPLETED UNDER ISO 10993 SERIES PASSED. NO DEVICE PROBLEM COULD BE FOUND.

    Description of Event or Problem · 0

    AT 13:54PM ON (B)(6) 2024, WHEN USING THE INJECTION PEN NEEDLE TO INJECT INSULIN FOR THE PATIENT'S TREATMENT; AT 14:00PM, THE PATIENT'S PUNCTURE SITE APPEARED TO BE RED, SWOLLEN, HOT AND PAINFUL, AND OTHER ADVERSE REACTIONS, THEN STOPPED TO USE THIS NEEDLE; AT 14:05 , IT WAS FOUND THAT THE PATIENT'S INJECTION SITE APPEARED TO BE HARD AND RED SWOLLEN, THEN IMMEDIATELY ASKED FOR A SURGICAL CONSULTATION. AFTER THE CONSULTATION, THE DOCTOR USED TDP IRRADIATION, LOCAL ANTI-INFECTION TREATMENT, WHICH LEADED TO THE PATIENT'S PHYSICAL AND MENTAL DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1106555 CLICKFINE 32GX4MM DONGBAO 7ER PEN NEEDLE FMI YPSOMED AG CLICKFINE 32GX4MM DONGBAO 7ER 231121-02

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention