BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES,LP

    MDR report key: 22871940 · Received August 22, 2025

    Report

    Report Number
    3003560965-2025-00017
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    July 25, 2025
    Report Date
    August 22, 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.PRODUCTION PROCESS REVIEW: THE PRODUCTION RECORDS OF THIS BATCH WERE EXAMINED, SHOWING NO ABNORMALITIES DURING THE MANUFACTURING PROCESS. THE INVESTIGATION WAS CONDUCTED FROM THE FOLLOWING ASPECTS: PERSONNEL: ALL PRODUCTION OPERATORS WERE PROPERLY TRAINED AND CERTIFIED BEFORE ASSIGNMENT. AS THE PRODUCT IS ASSEMBLED USING AUTOMATED EQUIPMENT WITH NO PROCESSING ERRORS, THIS FACTOR CAN BE EXCLUDED. EQUIPMENT: PRODUCTION EQUIPMENT UNDERGOES DAILY INSPECTIONS AND REGULAR MAINTENANCE. FIRST-ARTICLE INSPECTIONS ARE CONDUCTED AT EACH SHIFT CHANGEOVER WITH NO ANOMALIES DETECTED, RULING OUT THIS FACTOR. MATERIALS: NO CHANGES WERE MADE TO RAW MATERIALS. INCOMING NEEDLE TUBES UNDERGO RIGIDITY AND TOUGHNESS TESTING PRIOR TO USE, AND FINISHED PRODUCTS ARE SIMILARLY TESTED BEFORE RELEASE, EXCLUDING THIS FACTOR. METHOD: NO MODIFICATIONS WERE MADE TO THE PRODUCTION PROCESS. HOWEVER, THE NEEDLE TUBES OF THIS SPECIFICATION (30G) ARE PARTICULARLY SLENDER AND PRONE TO BENDING UNDER FORCE. EXCESSIVE BENDING BEYOND THE TUBE'S TOLERANCE LIMIT (NORMAL RANGE: 25¡Ã) DURING CLINICAL PROCEDURES MAY LEAD TO FRACTURE. ENVIRONMENT: THE PRODUCT IS ASSEMBLED IN A CONTROLLED CLEANROOM ENVIRONMENT. AS THE NEEDLE FRACTURE OCCURRED DURING USAGE, PRODUCTION ENVIRONMENTAL FACTORS CAN BE EXCLUDED. BATCH SAMPLE TESTING: TEN RETAINED SAMPLES FROM BATCH 220411 (SPECIFICATION: 30G¡Á0.5" HYPODERMIC NEEDLES) WERE TESTED AS FOLLOWS: VISUAL INSPECTION: ALL SAMPLES SHOWED COMPLETE BONDING BETWEEN NEEDLE TUBES AND HUBS WITH SUFFICIENT ADHESIVE FILL. NO PHYSICAL DEFECTS WERE OBSERVED ON ANY NEEDLE TUBES. PERFORMANCE TESTING: ALL 10 SAMPLES PASSED RIGIDITY AND TOUGHNESS TESTING PER ISO 7864:2016 REQUIREMENTS. DETAILED RESULTS ARE DOCUMENTED IN THE RETAINED SAMPLE TEST REPORT. ROOT CAUSE ANALYSIS: BASED ON THE INVESTIGATION, THE PROBABLE CAUSE IS THE INHERENT SLENDERNESS OF THIS NEEDLE SPECIFICATION (30G). DURING CLINICAL USE, EITHER IMPROPER HANDLING TECHNIQUE OR EXCESSIVE PATIENT MOVEMENT MAY HAVE CAUSED THE NEEDLE TUBE TO BEND BEYOND ITS MECHANICAL TOLERANCE (25¡Ã MAXIMUM BEND ANGLE), RESULTING IN FRACTURE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE NEEDLE BROKE INSIDE THE PATIENT'S BODY DURING INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2656315 MEDLINE INDUSTRIES,LP HYPDERMIC NEEDLE FMI ZHEJIANG KINDLY MEDICAL DEVICES CO.,LTD 30G¡Á0.5'' 220411 30080196305630

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown