BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN INC

    MDR report key: 23165057 · Received September 29, 2025

    Report

    Report Number
    3003560965-2025-00026
    Event Type
    Malfunction
    Date Received
    September 29, 2025
    Date of Event
    September 11, 2025
    Report Date
    September 29, 2025
    Manufacturer
    ZHEJIANG KINDLY MEDICAL DEVICES CO.,LTD
    Product Code
    FMI
    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: THE PRODUCTION RECORDS OF THE BATCH WERE EXAMINED, AND NO ABNORMALITIES WERE FOUND IN THE MANUFACTURING PROCESS. THE RAW MATERIALS AND PRODUCTION TECHNIQUES FOR THE PRODUCT REMAINED UNCHANGED. THE PRODUCT IS ASSEMBLED USING AN AUTOMATIC ASSEMBLY MACHINE, WHICH INCLUDES A CLOGGING AND LEAKAGE INSPECTION STEP TO TEST EACH INDIVIDUAL PIECE. ANY DEFECTIVE PRODUCTS ARE AUTOMATICALLY REJECTED. BEFORE EACH SHIFT, INSPECTION PERSONNEL VERIFY THE FUNCTIONALITY OF THIS DETECTION SYSTEM, AND PRODUCTION ONLY PROCEEDS IF IT IS CONFIRMED TO BE OPERATING NORMALLY. 2. BATCH SAMPLE TESTING: A SAMPLE OF 10 PIECES FROM BATCH NUMBER: 20241120, SPECIFICATION 27G*1 1/4'' HYPODERMIC NEEDLES, WAS TAKEN FOR TESTING: (1) FIVE UNITS WERE TESTED FOR LUMEN PATENCY IN ACCORDANCE WITH ISO 7864:2016 STANDARDS. THE TEST RESULTS MET THE REQUIREMENTS, AS DETAILED IN APPENDIX 1. (2) FIVE UNITS WERE TESTED TO SIMULATE CLINICAL USE FOR FLUID ASPIRATION AND INJECTION. ALL SAMPLES WERE UNOBSTRUCTED, WITH NO CLOGGING OBSERVED. 3. CAUSE ANALYSIS: IT IS POSSIBLE THAT DURING CLINICAL PRACTICE, THE HYPODERMIC NEEDLE WAS USED DIRECTLY TO PUNCTURE MEDICATION VIALS FOR DRUG PREPARATION OR WITHDRAWAL, AND IN THE PROCESS OF PIERCING THE RUBBER STOPPER, DEBRIS WAS GENERATED, LEADING TO NEEDLE BLOCKAGE. IT IS POSSIBLE THAT THE MEDICATION USED IN THE CLINICAL SETTING WAS OF A VISCOUS NATURE, RESULTING IN A CLOGGING PHENOMENON. IT IS POSSIBLE THAT OTHER INFUSION DEVICES USED IN CONJUNCTION WITH THE NEEDLE IN THE CLINICAL SETTING WERE ABNORMAL, CAUSING THE NEEDLE TO FAIL TO DELIVER FLUID.

    Description of Event or Problem · 0

    THE CUSTOMER ADVISED THAT THE NEEDLES ARE CLOGGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1797666 HENRY SCHEIN INC HYPODERMIC NEEDLES FMI ZHEJIANG KINDLY MEDICAL DEVICES CO.,LTD 27G*1 1/4'' 20241120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown