BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES,LP

    MDR report key: 22912003 · Received August 28, 2025

    Report

    Report Number
    3003560965-2025-00021
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    July 25, 2025
    Report Date
    August 28, 2025
    Manufacturer
    ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.
    Product Code
    FMI
    UDI-DI
    30080196305630
    PMA / PMN Number
    K112057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1.REVIEW OF PRODUCTION PROCESS: THE BATCH RECORDS AND FINISHED PRODUCT INSPECTION REPORTS WERE TRACED, AND NO ABNORMALITIES WERE FOUND DURING THE PRODUCTION PROCESS OR FINAL PRODUCT INSPECTION. THE FINISHED PRODUCT PASSED THE FACTORY INSPECTION. ANALYSIS WAS CONDUCTED FROM THE FOLLOWING ASPECTS: PERSONNEL: PRODUCTION AND INSPECTION PERSONNEL WERE TRAINED AND QUALIFIED BEFORE WORKING. THERE WERE NO PROCESSING ERRORS, SO THIS FACTOR CAN BE EXCLUDED. EQUIPMENT: THE PRODUCT WAS ASSEMBLED USING AN AUTOMATIC ASSEMBLY MACHINE. THE EQUIPMENT UNDERWENT DAILY CHECKS AND REGULAR MAINTENANCE, AND FIRST-PIECE INSPECTIONS WERE PERFORMED AT THE START OF EACH SHIFT. THIS FACTOR CAN BE EXCLUDED. MATERIALS: THE RAW MATERIALS USED FOR THE PRODUCT WERE UNCHANGED. THE DETACHMENT OF THE NEEDLE FROM THE SYRINGE IS RELATED TO THE DIMENSIONAL FIT OF THE LUER CONNECTOR BETWEEN THEM, SO THIS FACTOR REMAINS UNDER CONSIDERATION. METHOD: THE PRODUCTION PROCESS WAS UNCHANGED, SO THE PRODUCTION METHOD FACTOR CAN BE EXCLUDED. HOWEVER, SINCE THE NEEDLE IS SMALL AND THE INJECTION PRESSURE IS HIGH, IMPROPER TIGHTENING DURING USE MAY LEAD TO DETACHMENT. ENVIRONMENT: THE PRODUCT WAS ASSEMBLED IN A CLEANROOM, SO THE PHENOMENON IS UNRELATED TO THE PRODUCTION ENVIRONMENT. HOWEVER, TRANSPORTATION AND STORAGE CONDITIONS (E.G., EXCESSIVE EXTERNAL FORCE DURING HANDLING OR STACKING TOO HIGH) MAY DEFORM OR DAMAGE THE NEEDLE HUB, LEADING TO LOOSENING DURING USE. MEASUREMENT: INSPECTION REPORTS CONFIRMED THAT THE LUER CONNECTOR DIMENSIONS MET REQUIREMENTS DURING FACTORY TESTING. 2.RETAINED SAMPLE TESTING: 10 RETAINED SAMPLES OF BATCH 230701 (SPECIFICATION: 30G*0.5'') WERE TESTED: 1) VISUAL INSPECTION SHOWED ALL NEEDLE HUBS WERE INTACT, WITH NO DEFECTS OR CRACKS. TAPER TESTING WITH PLUG GAUGES CONFIRMED COMPLIANCE. 2)5 SAMPLES WERE TESTED PER ISO 80369-7 FOR LUER CONNECTOR DIMENSIONS, RESISTANCE TO TORQUE SEPARATION, AND RESISTANCE TO AXIAL LOAD SEPARATION ALL PASSED. 3)FIVE SAMPLES WERE CONNECTED TO THREADED SYRINGES FOR SIMULATED CLINICAL INJECTION TESTING, WITH NO ABNORMALITIES OBSERVED. 3.ROOT CAUSE ANALYSIS: BASED ON THE INVESTIGATION, THE POSSIBLE CAUSES ARE: 1) DEFORMATION OR DAMAGE TO THE NEEDLE HUB, SUCH AS FROM EXTERNAL IMPACT OR EXCESSIVE PRESSURE DURING TRANSPORTATION OR STORAGE, LEADING TO DETACHMENT DURING USE. 2)IMPROPER TIGHTENING OR FITTING DURING CLINICAL USE, CAUSING THE NEEDLE TO DETACH DURING INJECTION.

    Description of Event or Problem · 0

    THE NEEDLE TUBE WAS FALLEN OFF FROM THE SYRINGE WHEN INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1834144 MEDLINE INDUSTRIES,LP HYPODERMIC NEEDLE FMI ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. 30G*0.5'' 230701 30080196305630

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown