BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLICKFINE 32GX4MM DONGBAO 7CT

    MDR report key: 17701945 · Received September 7, 2023

    Report

    Report Number
    3002806818-2023-00010
    Event Type
    Malfunction
    Date Received
    September 7, 2023
    Date of Event
    June 20, 2023
    Report Date
    September 7, 2023
    Manufacturer
    YPSOMED AG
    Product Code
    FMI
    PMA / PMN Number
    K171984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE HOSPITAL'S PHARMACY OBSERVED A DAMAGED PEEL FOIL, A STERILE BARRIER, PRIOR TO USE. THE REVIEW OF MANUFACTURING HISTORY SHOWED NO ABNORMALITIES OR DEVIATIONS FROM THE VALIDATED MANUFACTURING PROCESS FROM THE MAIN BATCH 221225. NO ABNORMALITIES WERE FOUND ON THE PEEL FOIL OR SEAL SEAM OF RETAINED SAMPLES OF THE SAME BATCH. THE PRODUCT WAS NOT USED ON A PATIENT.

    Description of Event or Problem · 0

    THE HOSPITAL'S PHARMACY OBSERVED A DAMAGED PEEL FOIL, A STERILE BARRIER, PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100713 CLICKFINE 32GX4MM DONGBAO 7CT PEN NEEDLE FMI YPSOMED AG CLICKFINE 32GX4MM DONGBAO 7CT 211225-02

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown