BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JIANGSU MICSAFE MEDICAL TECHNOLOGY CO.,LTD

    MDR report key: 23106716 · Received September 22, 2025

    Report

    Report Number
    3003560965-2025-00024
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    September 1, 2025
    Report Date
    September 22, 2025
    Manufacturer
    ZHEJIANG KINDLY MEDICAL DEVICES CO.,LTD
    Product Code
    JKA
    PMA / PMN Number
    K172763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1. PRODUCTION PROCESS REVIEW: BASED ON THE BATCH NUMBER, THE PRODUCTION PROCESS BATCH RECORDS AND FINISHED PRODUCT INSPECTION REPORTS OF THIS BATCH OF PRODUCTS WERE TRACED. NO ABNORMAL SITUATIONS WERE FOUND DURING THE PRODUCTION PROCESS AND FINISHED PRODUCT INSPECTION, AND THE PRODUCTION PROCESS AND RAW MATERIALS DID NOT CHANGE. 2. SAMPLE RETENTION INSPECTION: 25 SAFETY BLOOD COLLECTION NEEDLES WITH BATCH NUMBER 220615 AND SPECIFICATION 22G*1 1/4 '' WERE RETAINED FOR TESTING. 1) APPEARANCE INSPECTION SHOWS THAT THE ADHESIVE BETWEEN THE NEEDLE HUB AND NEEDLE TUBE IS FULL, AND ALL COMPONENTS ARE UNDAMAGED. 2) USING 10 RETAINED SAMPLES FOR FIRMNESS TESTING, A STATIC AXIAL TENSILE FORCE OF 20N WAS APPLIED TO THE CONNECTION BETWEEN THE NEEDLE TUBE AND THE NEEDLE HUB/NEEDLE HANDLE, AND NO LOOSENESS WAS OBSERVED AFTER TESTING. 3) USING 15 SAFETY BLOOD COLLECTION NEEDLES TO SIMULATE CLINICAL BLOOD SAMPLE COLLECTION TESTING, NO ABNORMAL SITUATIONS OF NEEDLE TUBE DETACHMENT WERE FOUND. 3. CAUSE ANALYSIS: ACCORDING TO THE PICTURES PROVIDED BY THE CUSTOMER, THE NEEDLE TUBE FALLS OFF (SEPARATES) FROM THE NEEDLE HUB AFTER BEING INSERTED INTO THE COLLECTION TUBE. THE CLAMPING FORCE OF THE COLLECTION TUBE ON THE NEEDLE TUBE IS USUALLY SMALL, AND PRELIMINARY ANALYSIS SUGGESTS THAT IT MAY BE A SAFETY BLOOD COLLECTION NEEDLE. DURING THE ASSEMBLY PROCESS, THERE WERE OCCASIONAL CASES WHERE THE NEEDLE TUBE WAS CONTAMINATED WITH OIL, RESULTING IN WEAK ADHESION BETWEEN THE NEEDLE HUB AND THE NEEDLE TUBE, CAUSING THE NEEDLE TUBE TO DETACH FROM THE NEEDLE HUB.

    Description of Event or Problem · 0

    AFTER PERFORMING VENIPUNCTURE, THE NEEDLE DETACHED FROM THE SAFETY MECHANISM AND PENETRATED THROUGH THE BOTTOM OF THE NEEDLE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2700244 JIANGSU MICSAFE MEDICAL TECHNOLOGY CO.,LTD SAFETY BLOOD COLLECTION NEEDLES JKA ZHEJIANG KINDLY MEDICAL DEVICES CO.,LTD 22G*1 1/4'' 220615

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown