BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES,LP

    MDR report key: 23540473 · Received November 13, 2025

    Report

    Report Number
    3003560965-2025-00030
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Date of Event
    November 6, 2025
    Report Date
    November 13, 2025
    Manufacturer
    ZHEJIANG KINDLY MEDICAL DEVICES CO.,LTD
    Product Code
    FMI
    PMA / PMN Number
    K233037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1. PRODUCTION PROCESS REVIEW: TRACING THE PRODUCTION PROCESS BATCH RECORDS AND FINISHED PRODUCT FACTORY INSPECTION REPORTS OF THIS BATCH OF PRODUCTS, NO ABNORMAL SITUATIONS WERE FOUND DURING THE PRODUCTION PROCESS AND FINISHED PRODUCT INSPECTION. FINISHED PRODUCT FACTORY INSPECTION VERIFIED AS QUALIFIED. 2. SAMPLE TESTING:BATCH NUMBER: 250310, SPECIFICATION: 23G*1.0''(25MM). 20 SAMPLES FROM THIS BATCH WILL BE RETAINED FOR TESTING: 1) APPEARANCE INSPECTION SHOWS THAT THE NEEDLE HUBS ARE INTACT WITHOUT ANY DEFECTS OR BREAKAGES, AND A TAPER TEST IS CONDUCTED USING A PLUG GAUGE, ALL OF WHICH ARE QUALIFIED. 2) ACCORDING TO THE REQUIREMENTS OF ISO 80369-7 STANDARD, THE RETAINED SAMPLES WERE SUBJECTED TO ANTI ROTATION TORQUE SEPARATION TEST AND ANTI AXIAL LOAD SEPARATION TEST, AND ALL SAMPLES WERE TESTED AND FOUND TO BE QUALIFIED. 3) FIVE ADDITIONAL SAMPLES WERE EXTRACTED AND CONNECTED TO THE SYRINGE FOR SIMULATED CLINICAL DRUG TESTING. THE TESTING PROCESS WAS SMOOTH AND NO ABNORMALITIES WERE FOUND. 3. CAUSE ANALYSIS: BASED ON THE ABOVE INVESTIGATION, OUR COMPANY'S PRODUCTS ARE QUALIFIED AND NO ABNORMAL SITUATIONS HAVE BEEN FOUND. WE NOW ANALYZE THE TRANSPORTATION AND USAGE PROCESS OF THE PRODUCT AS FOLLOWS: 1) DUE TO THE CUSTOMER FEEDBACK THIS TIME, IT WAS FOUND THAT THERE WERE ISSUES WITH THE NEEDLE AND SYRINGE BEING DETACHED AND LEAKING WHEN THEY WERE CONNECTED IN A CERTAIN BOX OF PRODUCTS. THEREFORE, OUR PRELIMINARY ANALYSIS SUGGESTS THAT THE HYPODERMIC NEEDLE MAY HAVE FALLEN OFF OR LEAKED DURING TRANSPORTATION, VIOLENT LOADING AND UNLOADING CAN CAUSE DEFORMATION OR DAMAGE TO THE NEEDLE HUB, AND THIS PHENOMENON IS ALSO MORE CONCENTRATED INSIDE ONE OR TWO BOXES. 2) MEANWHILE, DIFFERENT DRUGS USED IN CLINICAL PRACTICE CAN ALSO AFFECT THE FIRMNESS OF THE NEEDLE HUB CONNECTION, SUCH AS LIPIDS OR OILY DRUGS THAT MAY CAUSE THE NEEDLE HUB TO SLIP AND FAIL TO TIGHTEN.

    Description of Event or Problem · 0

    WE HAVE ENCOUNTERED AN ISSUE WITH ONE BOX OF OUR MEDLINE 23G HYPODERMIC NEEDLES (REF: (B)(6), LOT: 250310). ON SEVERAL OCCASIONS, AND WITH DIFFERENT NURSES, THE SYRINGE HAS DETACHED IMMEDIATELY UPON ADMINISTERING AN INJECTION, CAUSING THE CONTENTS TO SPRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2120011 MEDLINE INDUSTRIES,LP HYPODERMIC NEEDLE FMI ZHEJIANG KINDLY MEDICAL DEVICES CO.,LTD 23G*1.0''(25MM) 250310

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown