BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES,LP

    MDR report key: 21176018 · Received January 17, 2025

    Report

    Report Number
    3003560965-2025-00002
    Event Type
    Malfunction
    Date Received
    January 17, 2025
    Date of Event
    January 8, 2025
    Report Date
    January 17, 2025
    Manufacturer
    ZHEJIANG KINDLY MEDICAL DEVICES CO.,LTD
    Product Code
    FMI
    UDI-DI
    30080196305630
    PMA / PMN Number
    K112057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (1) BATCH SAMPLE TEST: ON JANUARY 8, 2025, 20 SAMPLES OF HYPODERMIC NEEDLES WITH BATCH NUMBER: 240505 AND SPECIFICATION: 30G*0.5" WERE EXTRACTED AND TESTED AS FOLLOWS: 1. PATENCY TEST OF NEEDLE LUMEN: ACCORDING TO THE REQUIREMENTS OF ISO7864-2016(E) STANDARD, 10 SAMPLES WERE TAKEN FOR TESTING. THE 0.18MM STYLET WAS USED TO PASS THROUGH THE NEEDLE LUMEN, AND THE STYLET COULD BE DROPPED FREELY. 2.SIMULATED CLINICAL USE FOR SUCTION INJECTION TEST: 10 HYPODERMIC NEEDLES WERE TAKEN TO SIMULATE CLINICAL PRACTICE FOR SUCTION INJECTION LIQUID, AND THE SIMULATION TEST RESULTS: ALL WERE UNOBSTRUCTED. (2)PRODUCTION PROCESS REVIEW: ACCORDING TO THE BATCH NUMBER, THE BATCH RECORD OF THE PRODUCTION PROCESS AND THE FINISHED PRODUCT INSPECTION REPORT ARE TRACED BACK, AND NO SUCH ABNORMAL SITUATION IS FOUND IN THE PRODUCTION PROCESS AND THE FINISHED PRODUCT INSPECTION PROCESS. (3) CAUSE ANALYSIS: THROUGH THE ABOVE SAMPLE RETENTION AND PRODUCTION PROCESS REVIEW SURVEY, NO SUCH ABNORMAL SITUATION WAS FOUND. COMBINED WITH CUSTOMER FEEDBACK INFORMATION, THE PRELIMINARY ANALYSIS OF THE CAUSE OF HYPODERMIC NEEDLE BLOCKAGE IS AS FOLLOWS: 1. BLOCKAGE OF SILICONE OIL IN NEEDLE TUBE: HYPODERMIC NEEDLE PRODUCTS IN THE PRODUCTION PROCESS OF SILICIFICATION HAVE ONLINE DETECTION OF BLOCKAGE FULL INSPECTION, IF THERE IS A BLOCKAGE WILL BE AUTOMATICALLY REMOVED, AND THERE ARE BLOWING CONTROL IN THE PROCESS OF SILICIFICATION, AND OUR COMPANY FOR THE HYPODERMIC NEEDLE FLOW PROBLEM, THE FACTORY BEFORE EACH SHIFT SET UP FULL-TIME INSPECTORS, WITH A SPECIAL DEFECTIVE PRODUCT DETECTION GROUP INSTALLED MACHINE ONLINE DETECTION FUNCTION SENSITIVE BEFORE PRODUCTION, EACH BATCH OF PRODUCTS BEFORE THE PRODUCTION PROCESS HAS A FIRST INSPECTION. SAMPLING INSPECTION (ONCE /4H) WAS CARRIED OUT DURING THE PROCESS, AND FINISHED PRODUCT INSPECTION WAS CARRIED OUT AFTER THE FINISHED PRODUCT. NO SUCH BLOCKAGE WAS FOUND DURING THE WHOLE PROCESS OF PRODUCT PRODUCTION AND FINISHED PRODUCT INSPECTION, SO THE INFLUENCE PROBABILITY OF THIS FACTOR IS VERY LOW. 2.CORING AND FRAGMENTATION BLOCKAGE: DUE TO CLINICAL PRACTICE, THE HYPODERMIC NEEDLE IS USED TO PUNCTURE THE MEDICINE BOTTLE STOPPER FOR ADDING MEDICINE, EXTRACTING MEDICINE, THE FALLING DEBRIS ON THE BOTTLE STOPPER OR OTHER CONDITIONS LEADING TO THE BLOCKAGE OF THE HYPODERMIC NEEDLE.

    Description of Event or Problem · 0

    CLOGGING NEEDLES/SYRINGES IT HAS BEEN AN ONGOING ISSUE WITH THE BD LUER LOCK 3 ML AND THE 30 GAUGE HYPODERMIC NEEDLES. IT OCCURS DAILY, SOMETIMES MULTIPLE TIMES WITH THE SAME SYRINGE AND WE KEEP HAVING TO CHANGE THE NEEDLES AS THE SYRINGE KEEPS CLOGGING. IT'S HAPPENING WITH ALL OF OUR PROVIDERS. UNFORTUNATELY, I NEED TO USE 3 ML SYRINGES AS I DO LARGER PROCEDURES, SO DON'T HAVE ANY OTHER ALTERNATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017328 MEDLINE INDUSTRIES,LP HYPODERMIC NEEDLE FMI ZHEJIANG KINDLY MEDICAL DEVICES CO.,LTD 30GX0.5" 240505 30080196305630

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown