BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES,LP

    MDR report key: 23540470 · Received November 13, 2025

    Report

    Report Number
    3003560965-2025-00031
    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
    UDI-DI
    40080196305576
    PMA / PMN Number
    K233037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1. PRODUCTION PROCESS REVIEW: BASED ON THE BATCH NUMBER, THE PRODUCTION PROCESS BATCH RECORDS AND FINISHED PRODUCT INSPECTION REPORTS OF THIS BATCH OF PRODUCTS WERE TRACED, AND NO SUCH ABNORMAL SITUATIONS WERE FOUND DURING THE PRODUCTION PROCESS AND FINISHED PRODUCT INSPECTION PROCESS. 2. SAMPLE RETENTION TESTING: 10 SAMPLES FROM LOT: 250419 25G*1.5''(38MM) RETENTION SAMPLES AND CONDUCT THE FOLLOWING TESTS: 1) FIVE SAMPLES WERE TAKEN FOR RETENTION, AND THE NEEDLE TUBES WERE TESTED FOR PATENCY ACCORDING TO THE REQUIREMENTS OF ISO7864-2016 (E) STANDARD. AFTER TESTING, ALL NEEDLE TUBES WERE FOUND TO BE UNOBSTRUCTED AND NO BLOCKAGE WAS FOUND. 2) ANOTHER 5 SAMPLES WERE TAKEN TO SIMULATE CLINICAL USE FOR SUCTIONING MEDICATION, AND AFTER TESTING, ALL THE NEEDLE TUBES WERE ALSO UNOBSTRUCTED AND UNOBSTRUCTED 3. CAUSE ANALYSIS: 1) PRODUCTION PROCESS ANALYSIS: DURING THE PRODUCTION PROCESS, OUR COMPANY'S NEEDLE TUBES UNDERGO AUTOMATIC VENTILATION TESTING ON EACH TUBE. IF ANY DEFECTIVE PRODUCTS ARE FOUND TO BE BLOCKED, THEY WILL BE AUTOMATICALLY REMOVED BY THE EQUIPMENT; AT THE SAME TIME, OUR INSPECTORS CONDUCT RANDOM CHECKS ON THE PRODUCED NEEDLE TUBES EVERY 4 HOURS AND CONDUCT SPECIAL INSPECTIONS FOR BLOCKAGES. THEREFORE, THE PROBABILITY OF NEEDLE TUBE BLOCKAGES IN OUR COMPANY IS RELATIVELY LOW. 2) ANALYSIS OF USAGE PROCESS: BASED ON OUR COMPANY'S PAST MARKET FEEDBACK EXPERIENCE, IT IS INFERRED THAT IT MAY BE DUE TO THE ACCIDENTAL DETACHMENT OF RUBBER PARTICLES FROM THE BOTTLE STOPPER OF THE MEDICINE BOTTLE DURING THE DISPENSING PROCESS OF THE NEEDLE TUBE, WHICH BLOCKED THE NEEDLE TUBE. DUE TO THE FACT THAT OUR PRODUCT IS SUITABLE FOR SUBCUTANEOUS INJECTION IN THE HUMAN BODY AND IS NOT DIRECTLY USED FOR DRUG DISPENSING AND DOSING, IT IS RECOMMENDED TO USE A DISPENSING NEEDLE IF MEDICATION IS NEEDED IN CLINICAL PRACTICE. 3) IT IS ALSO POSSIBLE THAT THE DRUGS USED IN CLINICAL PRACTICE ARE TOO VISCOUS, LEADING TO THE PHENOMENON OF NEEDLE BLOCKAGE. 4) IT MAY BE DUE TO ABNORMALITIES IN THE CLINICAL COMBINATION WITH OTHER INFUSION PRODUCTS, RESULTING IN THE INABILITY OF THE NEEDLE TO INJECT NORMALLY.

    Description of Event or Problem · 0

    THE NEEDLES ARE CLOGGING WITH THE INJECTIONS. CAUSING AN ISSUE WITH COMPLETING THE INJECTION, UNABLE AND NEED TO RE- STICK THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2120008 MEDLINE INDUSTRIES,LP HYPODERMIC NEEDLE FMI ZHEJIANG KINDLY MEDICAL DEVICES CO.,LTD 25G*1.5''(38MM) 250419 40080196305576

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown