BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLICKFINE 32GX4MM DONGBAO 7ER

    MDR report key: 19494343 · Received June 8, 2024

    Report

    Report Number
    3002806818-2024-00014
    Event Type
    Malfunction
    Date Received
    June 8, 2024
    Date of Event
    April 28, 2024
    Report Date
    June 7, 2024
    Manufacturer
    YPSOMED AG
    Product Code
    FMI
    PMA / PMN Number
    K171984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING AN INSULIN INJECTION BY A NURSE FOR THE PATIENT IN THE HOSPITAL, THE PATIENT FELT ABNORMAL PAIN. THE NEEDLE WAS BENT WHEN INSPECTED AFTERWARDS. NEEDLE WAS REPLACED TO COMPLETE THE THERAPY. SKIN REDNESS AND SWELLING WAS OBSERVED. THE BATCH RECORD REVIEW SHOWED NO ABNORMALITIES OR DEVIATIONS FROM THE VALIDATED MANUFACTURING PROCESS FOR THE MAIN BATCH 231235. PROCESS DOCUMENTATION WAS REVIEWED AND INVESTIGATION VERIFIED THAT BEFORE THE PEEL FOIL IS SEALED, THE ANGLE OF THE CANNULA CARTRIDGE END (WOBBLE CIRCLE) WAS CHECKED 100% DURING THE ASSEMBLY PROCESS. INSPECTION SORTS OUT NON-CONFORMING PARTS SUCH AS BENT CANNULA CARTDIGE. NO ERROR CAN BE FOUND.

    Description of Event or Problem · 0

    DURING AN INSULIN INJECTION BY A NURSE FOR THE PATIENT IN THE HOSPITAL, THE PATIENT FELT ABNORMAL PAIN. THE NEEDLE WAS BENT WHEN INSPECTED AFTERWARDS. NEEDLE WAS REPLACED TO COMPLETE THE THERAPY. SKIN REDNESS AND SWELLING WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2319957 CLICKFINE 32GX4MM DONGBAO 7ER PEN NEEDLE FMI YPSOMED AG CLICKFINE 32GX4MM DONGBAO 7ER 231235-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other