BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLICKFINE

    MDR report key: 13875138 · Received March 24, 2022

    Report

    Report Number
    3005170966-2022-00001
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    October 26, 2021
    Report Date
    April 15, 2024
    Manufacturer
    YPSOMED AG
    Product Code
    FMI
    PMA / PMN Number
    K171984
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021, IT WAS REPORTED THAT WHEN THE NURSE USED THE OUTER-PROTECTIVE CAP TO UNSCREW THE NEEDLE (ARTICLE 700000176, BATCH 201278-02) FROM THE PEN AFTER THE INJECTION, EVEN AFTER SEVERAL ROTATIONS, THE NEEDLE FAILED TO COMPLETELY UNSCREW FROM THE PEN. THE OUTER-PROTECTIVE CAP WAS PULLED OUT, BUT THE NEEDLE WAS STILL ATTACHED TO THE PEN. BECAUSE OF THIS, THE NURSE GOT SCRATCHED BY THE NEEDLE TIP. . THE INVESTIGATION STARTED WITH A REVIEW OF THE BATCH RECORD WHICH SHOWED NO ABNORMALITIES OR DEVIATION FROM THE VALIDATED MANUFACTURING PROCESS. A HANDLING TEST WAS THEN PERFORMED USING 5 SAMPLES FROM THE SAME BATCH. THE NEEDLES WERE CLICKED ONTO THE SERVOPEN AND AN INJECTION WAS SIMULATED BY PIERCING ON AN INJECTION PAD. AFTERWARDS, THE OUTER PROTECTIVE CAP WAS USED TO UNSCREW THE NEEDLE FROM THE PEN. RESULTS SHOW THAT THE NEEDLES COULD BE UNSCREWED WITHOUT ANY PROBLEMS. SINCE NO INFORMATION WAS GIVEN PERTAINING TO THE PEN USED, A COMPATIBILITY TEST WITH DIFFERENT PENS WAS ALSO PERFORMED ACCORDING TO ISO11608-2:2012. RESULTS OF THE TEST REVEALED THAT THE NEEDLES ARE COMPATIBLE WITH ALL PENS AND PERFORMED AS EXPECTED. BASED ON THE INVESTIGATION PERFORMED, THE ISSUE REPORTED BY THE CUSTOMER CANNOT BE CONFIRMED OR RE-CREATED.

    Additional Manufacturer Narrative · 0

    ON 26TH OCT. 2021, IT WAS REPORTED THAT WHEN THE NURSE USED THE OUTER-PROTECTIVE CAP TO UNSCREW THE NEEDLE (ARTICLE: 700000176, BATCH 201278-02) FROM THE PEN AFTER THE INJECTION, EVEN AFTER SEVERAL ROTATIONS, THE NEEDLE FAILED TO COMPLETELY UNSCREW FROM THE PEN. THE OUTER-PROTECTIVE CAP WAS PULLED OUT, BUT THE NEEDLE WAS STILL ATTACHED TO THE PEN. BECAUSE OF THIS, THE NURSE GOT SCRATCHED BY THE NEEDLE TIP. THE INVESTIGATION STARTED WITH A REVIEW OF THE BATCH RECORD WHICH SHOWED NO ABNORMALITIES OR DEVIATION FROM THE VALIDATED MANUFACTURING PROCESS. A HANDLING TEST WAS THEN PERFORMED USING 5 SAMPLES FROM THE SAME BATCH. THE NEEDLES WERE CLICKED ONTO THE SERVOPEN AND AN INJECTION WAS SIMULATED BY PIERCING ON AN INJECTION PAD. AFTERWARDS, THE OUTER PROTECTIVE CAP WAS USED TO UNSCREW THE NEEDLE FROM THE PEN. RESULTS SHOW THAT THE NEEDLES COULD BE UNSCREWED WITHOUT ANY PROBLEMS. SINCE NO INFORMATION WAS GIVEN PERTAINING TO THE PEN USED, A COMPATIBILITY TEST WITH DIFFERENT PENS WAS ALSO PERFORMED ACCORDING TO ISO11608-2:2012. RESULTS OF THE TEST REVEALED THAT THE NEEDLES ARE COMPATIBLE WITH ALL PENS AND PERFORMED AS EXPECTED. BASED ON THE INVESTIGATION PERFORMED, THE ISSUE REPORTED BY THE CUSTOMER CANNOT BE CONFIRMED OR RE-CREATED.

    Description of Event or Problem · 0

    ON (B)(6) 2021, IT WAS REPORTED THAT WHEN THE NURSE DISASSEMBLED THE CLICKFINE NEEDLE 32GX4MM, AFTER INJECTION BY USING THE OUTER PROTECTIVE CAP, THE NURSE FAILED TO UNSCREW IT FROM THE PEN AND THE NURSE WAS SCRATCHED BY THE NEEDLE TIP. THERE WERE NO SERIOUS INJURY FOUND AFTER TREATMENT. UPDATE 11. MARCH 2022: THE INVESTIGATION REVEALED THAT WHEN THE NURSE USED THE OUTER-PROTECTIVE CAP TO UNSCREW THE NEEDLE FROM THE PEN AFTER THE INJECTION, EVEN AFTER SEVERAL ROTATIONS, THE NEEDLE FAILED TO COMPLETELY UNSCREW FROM THE PEN. THE OUTER-PROTECTIVE CAP WAS PULLED OUT, BUT THE NEEDLE WAS STILL ON THE PEN. BECAUSE OF THIS, THE NURSE GOT SCRATCHED BY THE NEEDLE TIP.

    Description of Event or Problem · 0

    ON 26TH OCT. 2021, IT WAS REPORTED THAT WHEN THE NURSE DISASSEMBLED THE CLICKFINE NEEDLE 32GX4MM, AFTER INJECTION BY USING THE OUTER PROTECTIVE CAP, THE NURSE FAILED TO UNSCREW IT FROM THE PEN AND THE NURSE WAS SCRATCHED BY THE NEEDLE TIP. THERE WERE NO SERIOUS INJURY FOUND AFTER TREATMENT. UPDATE 11. MARCH 2022: THE INVESTIGATION REVEALED THAT WHEN THE NURSE USED THE OUTER-PROTECTIVE CAP TO UNSCREW THE NEEDLE FROM THE PEN AFTER THE INJECTION, EVEN AFTER SEVERAL ROTATIONS, THE NEEDLE FAILED TO COMPLETELY UNSCREW FROM THE PEN. THE OUTER-PROTECTIVE CAP WAS PULLED OUT, BUT THE NEEDLE WAS STILL ON THE PEN. BECAUSE OF THIS, THE NURSE GOT SCRATCHED BY THE NEEDLE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728146 CLICKFINE PEN NEEDLE FMI YPSOMED AG CLICKFINE 32GX4MM DONGBAO 7CT 201278-02

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention