BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON GLOBAL SOURCING LTD

    MDR report key: 21604947 · Received March 14, 2025

    Report

    Report Number
    3003560965-2025-00011
    Event Type
    Malfunction
    Date Received
    March 14, 2025
    Report Date
    March 14, 2025
    Manufacturer
    ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.
    Product Code
    FMI
    UDI-DI
    10612479206790
    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 THE BATCH WERE CHECKED, AND NO ABNORMALITIES WERE FOUND IN THE PRODUCTION PROCESS. THE RAW MATERIALS AND PRODUCTION PROCESS FOR THE PRODUCT REMAINED UNCHANGED. THIS BATCH IS CONSISTENT WITH THE COMPLAINT (2025-MCKESSON-0202/GL-25-0063). 2. BATCH SAMPLE TESTING: ON (B)(6) 2025, 10 SAMPLES OF THE HYPODERMIC NEEDLES FROM BATCH NUMBER CKDJ08-04, SPECIFICATION 25G*5/8" (0.5MM*16MM), WERE TESTED AS FOLLOWS: - 1) NEEDLE LUMEN PATENCY TEST: ACCORDING TO THE ISO7864-2016(E) STANDARD, 5 SAMPLES WERE TESTED BY INSERTING A 0.23MM STYLET INTO THE NEEDLE LUMEN. THE STYLET PASSED THROUGH FREELY AND FELL OUT IN ALL CASES. TEST RESULTS: ALL PASSED. - 2) SIMULATED CLINICAL USE FOR LIQUID ASPIRATION AND INJECTION TEST: 5 SAMPLE NEEDLES WERE TESTED INDIVIDUALLY BY SIMULATING CLINICAL LIQUID ASPIRATION AND INJECTION. SIMULATED TEST RESULTS: ALL WERE UNOBSTRUCTED WITH NO BLOCKAGES. 3. CAUSE ANALYSIS: THE ABOVE SAMPLE TESTING AND PRODUCTION PROCESS REVIEW DID NOT REVEAL ANY SUCH ABNORMALITIES. BASED ON CUSTOMER FEEDBACK, THE PRELIMINARY ANALYSIS OF THE CAUSES FOR THE NEEDLE BLOCKAGE IS AS FOLLOWS: 1) SILICONE OIL BLOCKAGE IN THE NEEDLE: THE HYPODERMIC NEEDLES UNDERGO FULL INSPECTION FOR BLOCKAGES ONLINE AFTER SILICONIZATION DURING PRODUCTION. ANY BLOCKAGES ARE AUTOMATICALLY REMOVED. THE SILICONIZATION PROCESS INCLUDES AIR BLOWING CONTROL. ADDITIONALLY, TO ADDRESS NEEDLE PATENCY ISSUES, A DEDICATED INSPECTOR IS ASSIGNED AT THE START OF EACH SHIFT TO TEST THE SENSITIVITY OF THE ASSEMBLY MACHINE WITH SPECIALLY DESIGNED DEFECTIVE PRODUCTS BEFORE PRODUCTION BEGINS. EACH BATCH UNDERGOES INITIAL INSPECTION BEFORE PRODUCTION, PERIODIC SAMPLING DURING PRODUCTION (ONCE EVERY 4 HOURS), AND FINAL PRODUCT INSPECTION AFTER PRODUCTION. NO SUCH BLOCKAGE ISSUES WERE FOUND THROUGHOUT THE PRODUCTION AND FINAL INSPECTION PROCESSES, MAKING THE LIKELIHOOD OF THIS FACTOR VERY LOW. 2) BLOCKAGE DUE TO CORING AND FRAGMENTATION: IT IS COMMON IN CLINICAL SETTINGS TO USE HYPODERMIC NEEDLES TO PIERCE MEDICATION VIAL STOPPERS FOR DRUG ADDITION AND EXTRACTION. PARTICULATE MATTER FROM THE STOPPERS CAN LEAD TO NEEDLE BLOCKAGES.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THIS PARTICULAR LOT OF NEEDLES IS NOT EFFECTIVELY ADMINISTERING MEDICATIONS. THE CUSTOMER INDICATED THAT THE NEEDLES FROM THIS LOT WERE UNABLE TO PUSH METHYLPREDNISOLONE AND OTHER DRUGS THROUGH AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228994 MCKESSON GLOBAL SOURCING LTD NEEDLE FMI ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. 25G*5/8''(0.5MM*16MM) CKDJ08-04 10612479206790

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown