BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES,LP

    MDR report key: 24949210 · Received April 22, 2026

    Report

    Report Number
    3003560965-2026-00012
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    April 13, 2026
    Report Date
    April 21, 2026
    Manufacturer
    ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.
    Product Code
    FMI
    UDI-DI
    30080196305579
    PMA / PMN Number
    K233037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1. REVIEW OF PRODUCTION PROCESS: PRODUCTION RECORDS OF THIS BATCH WERE INSPECTED, AND NO ABNORMALITIES WERE FOUND DURING THE PRODUCTION PROCESS. INVESTIGATIONS WERE CONDUCTED FROM THE FOLLOWING ASPECTS: MANPOWER: ALL PRODUCTION OPERATORS WERE POST-QUALIFIED WITH TRAINING AND ASSESSMENT. THE PRODUCT IS ASSEMBLED BY AN AUTOMATIC ASSEMBLY MACHINE WITHOUT PROCESSING ERRORS, SO THIS FACTOR CAN BE EXCLUDED. MACHINE: PRODUCTION EQUIPMENT IS INSPECTED DAILY AND MAINTAINED REGULARLY. FIRST INSPECTION IS PERFORMED FOR EACH PRODUCTION SHIFT WITH NO ABNORMALITIES FOUND, SO THIS FACTOR CAN BE EXCLUDED. MATERIAL: NO CHANGES HAVE BEEN MADE TO THE RAW MATERIALS. RIGIDITY AND TOUGHNESS TESTS ARE CARRIED OUT DURING INCOMING INSPECTION OF NEEDLE TUBE, WHICH ARE ONLY PUT INTO USE UPON PASSING THE TESTS. FINISHED PRODUCTS ALSO UNDERGO RIGIDITY AND TOUGHNESS TESTS AND ARE ONLY RELEASED AFTER PASSING, SO THIS FACTOR CAN BE EXCLUDED. METHOD: THE PRODUCTION PROCESS OF THE PRODUCT REMAINS UNCHANGED, SO THE INFLUENCE OF PROCESS VARIATION CAN BE EXCLUDED. THE NEEDLE CANNULA OF THIS SPECIFICATION IS RELATIVELY THIN AND EASY TO BEND UNDER FORCE. DURING CLINICAL OPERATION, THE TUBE MAY BREAK IF BENT AT AN EXCESSIVE ANGLE. ENVIRONMENT: THE PRODUCT IS ASSEMBLED AND MANUFACTURED IN A CLEANROOM. THE NEEDLE BREAKAGE OCCURRED DURING USE, WHICH IS IRRELEVANT TO THE PRODUCTION ENVIRONMENT. 2. BATCH SAMPLE INSPECTION: TEN RETAINED SAMPLES OF THE HYPODERMIC NEEDLE WITH BATCH 250714 AND SPECIFICATION 25G 1.5" (38MM) WERE SELECTED FOR TESTING: VISUAL INSPECTION: ALL NEEDLE CANNULAS WERE WELL CONNECTED TO HUBS WITH SUFFICIENT ADHESIVE, AND ALL CANNULAS WERE INTACT WITHOUT ABNORMALITIES. RIGIDITY AND TOUGHNESS TESTS WERE PERFORMED IN ACCORDANCE WITH ISO 7864:2016, AND THE RESULTS MET THE REQUIREMENTS. 3. ROOT CAUSE ANALYSIS: BASED ON THE ABOVE INVESTIGATION, THE POSSIBLE CAUSE IS ANALYZED AS FOLLOWS: THE HYPODERMIC NEEDLE HAS A THIN CANNULA, AND IMPROPER OPERATION DURING CLINICAL USE OR EXCESSIVE MOVEMENT OF THE PATIENT DURING INJECTION CAUSED THE BENDING ANGLE OF THE NEEDLE CANNULA TO EXCEED ITS BEARING LIMIT (20° FOR THIN-WALL CANNULA), RESULTING IN BREAKAGE. ACCORDING TO CUSTOMER FEEDBACK, THE PRODUCT WAS USED ON THE PATIENT'S THYROID GLAND. THE CUSTOMER IS ADVISED TO FURTHER VERIFY THE SPECIFIC APPLICATION, AS SUCH PRODUCTS ARE NOT SUITABLE FOR CERTAIN ABLATION PROCEDURES.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE BROKE OFF INTO THE PATIENT'S THYROID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272903 MEDLINE INDUSTRIES,LP HYPODERMIC NEEDLE FMI ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. 25G*1.5''(38MM'') 250714 30080196305579

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown