BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERIC MEDICAL LLC

    MDR report key: 23797155 · Received December 13, 2025

    Report

    Report Number
    3003560965-2025-00032
    Event Type
    Malfunction
    Date Received
    December 13, 2025
    Date of Event
    November 27, 2025
    Report Date
    December 8, 2025
    Manufacturer
    ZHEJIANG KINDLY MEDICAL DEVICES CO.,LTD
    Product Code
    JKA
    UDI-DI
    10885380182952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCTION PROCESS REVIEW: TRACING THE PRODUCTION PROCESS BATCH RECORDS AND FINISHED PRODUCT FACTORY INSPECTION REPORTS OF THIS BATCH OF PRODUCTS, THERE HAVE BEEN NO CHANGES IN RAW MATERIALS AND PRODUCTION PROCESSES, AND THE FINISHED PRODUCT HAS PASSED THE FACTORY INSPECTION. 2. SAMPLE RETENTION TESTING: BATCH NUMBER: 241118 SPECIFICATION: 20G*19MM BLOOD COLLECTION NEEDLE, RETAIN 5 SAMPLES FOR TESTING: 1) APPEARANCE INSPECTION SHOWS THAT ALL COMPONENTS ARE UNDAMAGED AND NOT DETACHED. 2) USING 5 SIMULATED CLINICAL COLLECTION TESTS, CONNECT EACH BLOOD COLLECTION NEEDLE TO A 10KPA WATER PRESSURE CATHETER, AND COLLECT 5 VACUUM COLLECTION TUBES FROM EACH BLOOD COLLECTION NEEDLE, ALL OF WHICH CAN COLLECT NORMALLY WITHOUT BLOCKAGE. 3. CAUSE ANALYSIS: THE PRINCIPLE OF BLOOD COLLECTION WITH A BLOOD COLLECTION NEEDLE IS TO USE THE VACUUM NEGATIVE PRESSURE OF THE BLOOD COLLECTION TUBE AND HUMAN BLOOD PRESSURE TO DRAW BLOOD INTO THE BLOOD COLLECTION TUBE (COLLECTION TUBE). THE BLOOD COLLECTION NEEDLE ONLY PROVIDES A CHANNEL; BASED ON THE ABOVE SAMPLE SURVEYS, IT CAN BE USED NORMALLY, AND ACCORDING TO THE CUSTOMER'S DESCRIPTION, THE USER IS CONNECTED TO THE BLOOD CULTURE BOTTLE FOR COLLECTION, AND BLOOD CANNOT ENTER THE BLOOD CULTURE BOTTLE. IT IS UNDERSTOOD THAT THE BLOOD .THE CULTURE BOTTLE CANNOT BE DIRECTLY CONNECTED WITH ORDINARY INTRAVENOUS BLOOD COLLECTION NEEDLES OR SYRINGES.

    Description of Event or Problem · 0

    BLOOD SPECIMENS COULD NOT BE TRANSFERRED INTO BLOOD CULTURE BOTTLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2770846 MAVERIC MEDICAL LLC BLOOD TRANSFER ADAPTER JKA ZHEJIANG KINDLY MEDICAL DEVICES CO.,LTD 20G*19MM 241118 10885380182952

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown