BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLICKFINE 32GX4MM DONGBAO 7CT

    MDR report key: 14501051 · Received May 25, 2022

    Report

    Report Number
    3005170966-2022-00003
    Event Type
    Injury
    Date Received
    May 25, 2022
    Date of Event
    April 20, 2022
    Report Date
    May 25, 2022
    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

    IT WAS REPORTED THAT THE INJECTION WITH THE PEN NEEDLE (ARTICLE 700000176, BATCH 211168-01) WAS PAINFUL. THE CUSTOMER DIDN'T RETURN ANY NEEDLES FOR INVESTIGATION. THE INVESTIGATION STARTED WITH A REVIEW FOR ANY INTERNAL DEVIATIONS DURING PRODUCTION, SHOWED NO ABNORMALITIES OR DEVIATIONS FROM THE VALIDATED MANUFACTURING PROCESS. PENETRATION FORCE TESTING WAS PERFORMED WITH 5 SAMPLES RETAINED FROM THE SAME BATCH NUMBER ACCORDING THE INTERNAL PRODUCT SPECIFICATION. THE TESTING SET-UP INCLUDED SCREWING THE NEEDLE ONTO THE HOLDING FIXTURE AND REMOVING THE INNER- AND OUTER PROTECTIVE CAP. THE METHOD INCLUDED PENETRATION IN FOIL UP TO NOMINAL LENGTHS WITH A DEFINED SPEED. NONE OF THE NEEDLES TESTED FROM THE SAME BATCH REACHED BEYOND THE MAXIMUM PENETRATION FORCE OF 1.0N.

    Description of Event or Problem · 0

    ON (B)(6) 2022, WHILE THE PATIENT WAS PERFORMING AN INSULIN INJECTION, THERE WAS PAIN REPORTED ON THE INJECTION SITE. WHEN THE PATIENT COMPLETED THE INJECTION AGAIN AFTER REPLACING A NEW NEEDLE, THERE WAS STILL PAIN REPORTED AT INJECTION SITE. ON (B)(6)2022, WHILE THE PATIENT WAS PERFORMING AN INSULIN INJECTION, THERE WAS PAIN REPORTED ON THE INJECTION SITE. WHEN THE PATIENT COMPLETED THE INJECTION AGAIN AFTER REPLACING A NEW NEEDLE, THERE WAS STILL PAIN REPORTED AT INJECTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1815586 CLICKFINE 32GX4MM DONGBAO 7CT PEN NEEDLE FMI YPSOMED AG CLICKFINE 32GX4MM DONGBAO 7CT 211168-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other