BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN INC

    MDR report key: 24949209 · Received April 22, 2026

    Report

    Report Number
    3003560965-2026-00011
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    April 3, 2026
    Report Date
    April 21, 2026
    Manufacturer
    ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.
    Product Code
    FMI
    UDI-DI
    00304040003084
    PMA / PMN Number
    K112057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 PRODUCTION. NO CHANGES WERE MADE TO THE RAW MATERIALS OR PRODUCTION PROCESS OF THE PRODUCT. THE PRODUCT IS ASSEMBLED BY AN AUTOMATIC ASSEMBLY MACHINE EQUIPPED WITH A BLOCKAGE INSPECTION PROCESS, WHICH TESTS EACH PRODUCT INDIVIDUALLY. ANY DEFECTIVE PRODUCTS ARE AUTOMATICALLY REJECTED. BEFORE EACH SHIFT, INSPECTORS VERIFY THE INSPECTION FUNCTION, AND PRODUCTION IS ONLY CARRIED OUT WHEN THE FUNCTION IS CONFIRMED NORMAL. 2. BATCH SAMPLE TESTING FIVE RETAINED SAMPLES OF THE HYPODERMIC NEEDLE WITH BATCH NO. 20240728 AND SPECIFICATION 30G 1/2" WERE SELECTED FOR TESTING: 1) THREE SAMPLES WERE TESTED FOR LUMEN PATENCY IN ACCORDANCE WITH THE REQUIREMENTS OF ISO 7864:2016, AND THE TEST RESULTS MET THE SPECIFICATIONS. 2) TWO SAMPLES WERE TESTED FOR FLUID ASPIRATION AND INJECTION TO SIMULATE CLINICAL USE; ALL SAMPLES WERE UNOBSTRUCTED WITHOUT BLOCKAGE. 3.ROOT CAUSE ANALYSIS 1) THE BLOCKAGE MAY BE CAUSED BY CLINICAL PRACTICE OF USING THE HYPODERMIC NEEDLE TO PUNCTURE MEDICATION VIALS DIRECTLY FOR DRUG PREPARATION AND ASPIRATION, WHERE RUBBER STOPPER DEBRIS GENERATED DURING PUNCTURE CLOGS THE NEEDLE LUMEN. 2) THE BLOCKAGE MAY RESULT FROM THE HIGH VISCOSITY OF THE CLINICAL MEDICATION USED. 3) THE FAILURE OF FLUID DELIVERY THROUGH THE NEEDLE MAY BE ATTRIBUTED TO ABNORMALITIES IN OTHER SUPPORTING INFUSION DEVICES USED CLINICALLY.

    Description of Event or Problem · 0

    THE CUSTOMER ADVISED THAT THEIR CLINICAL STAFF, INCLUDING THE PHYSICIAN, HAVE REPORTED THAT THE NEEDLES SEEM TO BE CLOGGED, MAKING IT DIFFICULT FOR PRODUCT TO FLOW THROUGH PROPERLY DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111138 HENRY SCHEIN INC HYPODERMIC NEEDLES FMI ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. 30G*1/2'' 20240728 00304040003084

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown