BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN INC

    MDR report key: 24740502 · Received March 31, 2026

    Report

    Report Number
    3003560965-2026-00006
    Event Type
    Malfunction
    Date Received
    March 31, 2026
    Date of Event
    March 11, 2026
    Report Date
    March 26, 2026
    Manufacturer
    ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.
    Product Code
    FMI
    UDI-DI
    00304040002940
    PMA / PMN Number
    K110257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    1. PRODUCTION PROCESS REVIEW: A REVIEW WAS CONDUCTED ON THE BATCH RECORDS OF THE PRODUCTION PROCESS AND FINISHED PRODUCT RELEASE INSPECTION REPORTS. NO ABNORMALITIES WERE FOUND DURING PRODUCTION AND FINISHED PRODUCT INSPECTION, AND THE FINISHED PRODUCT PASSED THE RELEASE INSPECTION. ANALYSIS WAS CARRIED OUT FROM THE FOLLOWING ASPECTS: MAN: PRODUCTION AND INSPECTION PERSONNEL WERE POST-QUALIFIED AFTER TRAINING, AND NO PROCESSING ERRORS OCCURRED. THIS FACTOR CAN BE EXCLUDED. MACHINE: THE PRODUCT IS ASSEMBLED BY AN AUTOMATIC ASSEMBLY MACHINE. THE EQUIPMENT IS INSPECTED DAILY AND MAINTAINED REGULARLY. FIRST-ARTICLE INSPECTION IS PERFORMED FOR EACH SHIFT. THE AUTOMATIC ASSEMBLY MACHINE IS EQUIPPED WITH ON-LINE INSPECTION EQUIPMENT DURING ASSEMBLY, WHICH CAN MONITOR AND INSPECT NEEDLE TIPS IN REAL TIME AND REJECT DEFECTIVE PRODUCTS. THIS FACTOR CAN BE EXCLUDED. MATERIAL: THE RAW MATERIALS USED FOR THE PRODUCT REMAINED UNCHANGED; THIS FACTOR IS EXCLUDED. METHOD: THE PRODUCTION PROCESS REMAINED UNCHANGED; THE PRODUCTION METHOD FACTOR CAN BE EXCLUDED. ENVIRONMENT: THE PRODUCT IS ASSEMBLED IN A CLEAN WORKSHOP, AND THE PHENOMENON IS NOT RELATED TO THE PRODUCTION ENVIRONMENT. MEASUREMENT: ACCORDING TO THE INSPECTION REPORTS, NEEDLE TIPS WERE INSPECTED UPON PRODUCT RELEASE WITH QUALIFIED RESULTS. DURING PRODUCTION, THE AUTOMATIC ASSEMBLY MACHINE IS EQUIPPED WITH ON-LINE INSPECTION EQUIPMENT, WHICH CAN MONITOR AND INSPECT NEEDLE TIPS IN REAL TIME AND REJECT DEFECTIVE PRODUCTS. 2. RETAINED SAMPLE TESTING: TEN RETAINED SAMPLES OF BATCH NO.: 20250601, SPECIFICATION: 27G*1 1/4'' HYPODERMIC NEEDLE WERE SELECTED FOR TESTING: OBSERVED UNDER A 10¡ Á MAGNIFIER, THE NEEDLE TIPS WERE SHARP, FREE OF BURRS, HOOKS, ETC., MEETING THE REQUIREMENTS. PENETRATION FORCE TESTING WAS PERFORMED ON 5 RETAINED SAMPLES IN ACCORDANCE WITH ISO 7864-2016/GB 15811-2016. PENETRATION FORCE TEST RESULTS: 0.308N-0.322N, AVERAGE: 0.315N. ACCORDING TO THE REQUIREMENTS FOR NEEDLE TIP PENETRATION FORCE IN GB 15811-2016 SINGLE-USE HYPODERMIC NEEDLES (NO PENETRATION FORCE REQUIREMENTS SPECIFIED IN ISO 7864), THE TEST RESULTS OF THIS BATCH OF HYPODERMIC NEEDLES ALL MEET THE REQUIREMENT OF PENETRATION FORCE 0.70N FOR 0.4 GAUGE. 3. COMPARISON WITH PREVIOUS DATA OF THE SAME SPECIFICATION PROVIDED BY THE CUSTOMER IS AS FOLLOWS: 2020 BATCH NO.: 20200401, SPECIFICATION: 27G*1 1/4" PENETRATION FORCE TEST RESULTS: 0.420N-0.450N, AVERAGE: 0.442N. 2023 BATCH NO.: 20230802, SPECIFICATION: 27G*1 1/4" PENETRATION FORCE TEST RESULTS: 0.401N-0.465N, AVERAGE: 0.430N. BASED ON THE ABOVE REVIEW OF HISTORICAL PENETRATION FORCE DATA OF THE SAME SPECIFICATION OVER THE YEARS, THE PENETRATION FORCE OF OUR COMPANY'S 2025 BATCH PRODUCTS HAS BEEN IMPROVED.

    Description of Event or Problem · 0

    THE PATIENTS ARE REPORTING THE NEEDLE POKES SEEM MORE PAINFUL THAN USUAL, ALMOST LIKE THE NEEDLES ARE MORE DULL THAN NORMAL. ADDITIONAL QUESTIONS WERE EMAILED TO (B)(6) (HS FIELD REP), AND HE FORWARDED THE QUESTIONS TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228450 HENRY SCHEIN INC HYPODERMIC NEEDLES FMI ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. 27G*1 1/4'' 20250601 00304040002940

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown