BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES,LP

    MDR report key: 23106715 · Received September 22, 2025

    Report

    Report Number
    3003560965-2025-00025
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    September 4, 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. VERIFICATION AND TRACEABILITY RESULTS OF PRODUCTION PROCESS (TRACING BATCH RECORDS): CHECK THE PRODUCTION RECORDS OF LOT 240920 SPECIFICATION: 22G*1''(0.7MM* 25MM) PRODUCT. THERE ARE NO ABNORMALITIES IN THE PRODUCTION PROCESS OF THE PRODUCT, AND THE RAW MATERIALS AND PRODUCTION PROCESS HAVE NOT CHANGED. THE PRODUCT IS PRODUCED USING AN AUTOMATIC ASSEMBLY MACHINE, WHICH IS EQUIPPED WITH A BLOCKAGE DETECTION DEVICE TO DETECT BLOCKAGES ON EACH PRODUCT. IF THERE ARE BLOCKAGES, THEY WILL BE AUTOMATICALLY REMOVED. BEFORE EACH SHIFT, AN INSPECTOR CONFIRMS THE BLOCKAGE DETECTION FUNCTION, AND PRODUCTION CAN ONLY PROCEED IF THE FUNCTION IS NORMAL. 2. SAMPLE TESTING: BATCH NUMBER: 240920, SPECIFICATION: 22G* 1''(0.7MM * 25MM) BLOOD COLLECTION NEEDLE, 10 SAMPLES WERE COLLECTED FOR SIMULATED CLINICAL BLOOD SAMPLE COLLECTION TESTING. AFTER EACH BLOOD COLLECTION NEEDLE WAS EQUIPPED WITH A NEEDLE HOLDER, 5 BLOOD COLLECTION TUBES WERE COLLECTED, AND ALL THE SAMPLES USED FOR TESTING WERE COLLECTED NORMALLY. 3. CAUSE ANALYSIS: BASED ON THE ABOVE SAMPLE INVESTIGATION AND CUSTOMER FEEDBACK INFORMATION, THE CUSTOMER DID NOT PROVIDE SPECIFIC SAMPLES FOR ANALYSIS, SO WE CANNOT UNDERSTAND THE SPECIFIC SITUATION. OUR COMPANY CAN ONLY MAKE A POSSIBILITY ANALYSIS: THE BLOOD COLLECTION NEEDLE PRODUCT IS MAINLY USED TO BUILD A CHANNEL BETWEEN THE HUMAN VEIN AND THE COLLECTION TUBE, WHICH ALLOWS BLOOD TO ENTER THE COLLECTION TUBE, BUT THE TRANSFER OF BLOOD IS MAINLY POWERED BY THE COLLECTION TUBE (THE COLLECTION TUBE IS IN A NEGATIVE PRESSURE STATE, AND THE VENOUS PRESSURE IS HIGHER THAN THE COLLECTION TUBE, SO BLOOD CAN FLOW INTO THE COLLECTION TUBE). THEREFORE, PATIENTS WITH LOW BLOOD PRESSURE, THICK BLOOD, THIN OR UNFILLED VENOUS VESSELS, NEEDLE TIPS TIGHTLY AGAINST THE VESSEL WALL, AND INSUFFICIENT NEGATIVE PRESSURE IN THE COLLECTION TUBE MAY ALL CAUSE THE INABILITY TO DRAW BLOOD.

    Description of Event or Problem · 0

    ITEM WILL NOT DRAW BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2700243 MEDLINE INDUSTRIES,LP MULTI-SAMPLE NEEDLE JKA ZHEJIANG KINDLY MEDICAL DEVICES CO.,LTD 22G *1'' 240920

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown