BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLICKFINE 32GX4MM DONGBAO 7CT

    MDR report key: 17604014 · Received August 23, 2023

    Report

    Report Number
    3002806818-2023-00009
    Event Type
    Malfunction
    Date Received
    August 23, 2023
    Date of Event
    June 25, 2023
    Report Date
    August 23, 2023
    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

    THE PATIENT REPORTED TO THE HOSPITAL THAT INSULIN COULD NOT BE DELIVERED. AFTER THE NURSE'S INVESTIGATION, IT WAS FOUND THAT THE CARTRIDGE END CANNULA WAS BROKEN OFF/INCOMPLETE. THE NURSE REPLACED THE NEEDLE FOR THE PATIENT. THE REVIEW OF MANUFACTURING HISTORY SHOWED NO ABNORMALITIES OR DEVIATIONS FROM THE VALIDATED MANUFACTURING PROCESS FROM THE MAIN BATCH 221390. A 100% AUTOMATIC SORTING, IN-PROCESS TESTING FOR THE CANNULA CARTRIDGE END (WOBBLE CIRCLE) STRAIGHTNESS BEFORE PEELFOIL SEAL WAS ALSO REVIEWED. THE INSPECTION ENSURES THAT ONLY COMPLETE PEN NEEDLES (NEEDLE HUB AND CANNULA) LEAVE THE PRODUCTION LINE. THERE WERE NO ISSUES FOUND.

    Description of Event or Problem · 0

    THE PATIENT REPORTED TO THE HOSPITAL THAT INSULIN COULD NOT BE DELIVERED. AFTER THE NURSE'S INVESTIGATION, IT WAS FOUND THAT THE CARTRIDGE END CANNULA WAS BROKEN OFF/INCOMPLETE. THE NURSE REPLACED THE NEEDLE FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1525087 CLICKFINE 32GX4MM DONGBAO 7CT PEN NEEDLE FMI YPSOMED AG CLICKFINE 32GX4MM DONGBAO 7CT 221390-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown