BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPODERMIC SAFETY NEEDLE

    MDR report key: 22891553 · Received August 25, 2025

    Report

    Report Number
    3012116434-2025-00001
    Event Type
    Malfunction
    Date Received
    August 25, 2025
    Date of Event
    December 4, 2024
    Report Date
    August 25, 2025
    Manufacturer
    ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD.
    Product Code
    FMI
    PMA / PMN Number
    K211555
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THE MDR REPORTS MW 5163490 AND MW 5163491, ALTHOUGH THERE WERE NO PRODUCT BATCH NUMBERS IN THE REPORTS, WE INVESTIGATED AND ANALYZED PRODUCTS OF THE SAME SPECIFICATIONS FROM THE SAME PERIOD BASED ON THEIR EXPIRATION DATES. WE FOCUSED ON CHECKING THE SAMPLES AND BATCH RECORDS OF THE TWO BATCHES 20210202 AND 20210205 WITH THE SAME SPECIFICATIONS THAT WERE CLOSEST TO THE EXPIRATION DATE IN THE REPORTS, AND DID NOT FIND ANY ABNORMAL SITUATIONS OF SHEATH DETACHMENT. REGARDING THE DETACHMENT AND MISALIGNMENT OF THE SAFETY DEVICE, WE DISCOVERED THIS ISSUE DURING THE PRODUCTION PROCESS IN FEBRUARY 2023 AND HAVE UPGRADED AND IMPROVED THE ASSEMBLY MACHINE FOR THIS TYPE OF PRODUCT BY ADDING A SAFETY INJECTION NEEDLE SHEATH INSPECTION DEVICE AND CONFIRMING ITS EFFECTIVENESS.

    Description of Event or Problem · 0

    MDR REPORT MW5163490 AND MW5163491: ON (B)(6) 2024, AFTER ADMINISTERING THE FLU VACCINE, ATTEMPTS WERE MADE TO ENGAGE THE SAFETY MECHANISM ON THE NEEDLE. HOWEVER, THE MECHANISM DETACHED COMPLETELY WHILE I WAS HOLDING THE ANKLES OF A 7- MONTH-OLD PATIENT WITH ONE HAND AND THE EXPOSED NEEDLE IN THE OTHER. TO MITIGATE RISK, I PLACED THE NEEDLE AS FAR AWAY AS POSSIBLE FROM THE WORK AREA BEFORE PROCEEDING TO ADMINISTER THE FINAL VACCINE. UPON ATTEMPTING TO ENGAGE THE SAFETY MECHANISM ON THE SECOND NEEDLE, I OBSERVED THAT IT BECAME UNHINGED AND MISALIGNED, RENDERING IT NON-FUNCTIONAL. CONSEQUENTLY, I WAS UNABLE TO SAFELY ENGAGE THE MECHANISM ON THE SECOND NEEDLE AS WELL. THE NEEDLES BEING USED WUZHOU 25G X1" SAFETY NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1866194 HYPODERMIC SAFETY NEEDLE FMI ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD. 25GX1

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Male