BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN INC

    MDR report key: 24870246 · Received April 14, 2026

    Report

    Report Number
    3003560965-2026-00008
    Event Type
    Malfunction
    Date Received
    April 14, 2026
    Date of Event
    March 10, 2026
    Report Date
    April 14, 2026
    Manufacturer
    ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.
    Product Code
    FMI
    UDI-DI
    00030404000308
    PMA / PMN Number
    K112057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. THERE WERE NO CHANGES TO THE RAW MATERIALS OR PRODUCTION PROCESSES OF THE PRODUCT. THE PRODUCT IS ASSEMBLED USING AN AUTOMATIC ASSEMBLY MACHINE EQUIPPED WITH A BLOCKAGE AND LEAKAGE DETECTION PROCESS, WHICH INSPECTS EACH INDIVIDUAL PRODUCT. ANY DEFECTIVE PRODUCTS ARE AUTOMATICALLY REJECTED. INSPECTORS VERIFY THE DETECTION FUNCTION BEFORE EACH SHIFT COMMENCES; PRODUCTION ONLY PROCEEDS WHEN THE FUNCTION IS CONFIRMED NORMAL. 2. BATCH SAMPLE TESTING: FIVE RETAINED SAMPLES OF THE HYPODERMIC NEEDLE WITH BATCH NO.: 20250601 AND SPECIFICATION: 30G 1/2" WERE SELECTED FOR TESTING: TWO SAMPLES WERE RANDOMLY SELECTED FOR LUMEN PATENCY TESTING IN ACCORDANCE WITH THE REQUIREMENTS OF ISO 7864:2016, AND THE TEST RESULTS MET THE SPECIFICATIONS.THREE SAMPLES WERE RANDOMLY SELECTED FOR FLUID ASPIRATION AND INJECTION TESTING TO SIMULATE CLINICAL USE; ALL SAMPLES WERE UNOBSTRUCTED AND FREE OF BLOCKAGE. 3. ROOT CAUSE ANALYSIS: IT MAY BE THAT THE HYPODERMIC NEEDLE IS DIRECTLY USED TO PUNCTURE MEDICATION VIALS FOR DRUG PREPARATION AND ASPIRATION IN CLINICAL PRACTICE, RESULTING IN DEBRIS GENERATED DURING NEEDLE TIP PUNCTURE OF THE RUBBER SLEEVE, WHICH BLOCKED THE NEEDLE LUMEN. IT MAY BE THAT THE CLINICALLY USED DRUGS ARE VISCOUS SOLUTIONS, LEADING TO THE REPORTED "BLOCKAGE" PHENOMENON. IT MAY BE CAUSED BY ABNORMALITIES IN OTHER CLINICALLY MATCHED INFUSION DEVICES, RESULTING IN FAILURE OF FLUID DELIVERY THROUGH THE NEEDLE.

    Description of Event or Problem · 0

    THE CUSTOMER ADVISED THAT THE NEEDLES WERE PLUGGED AND THEY COULD NOT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541745 HENRY SCHEIN INC HYPODERMIC NEEDLES FMI ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. 30G*1/2'' 20250601 00030404000308

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown