BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES,LP

    MDR report key: 22911997 · Received August 28, 2025

    Report

    Report Number
    3003560965-2025-00020
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    July 25, 2025
    Report Date
    August 28, 2025
    Manufacturer
    ZHEJIANG KINDLY MEDICAL DEVICES CO.,LTD
    Product Code
    JKA
    UDI-DI
    10193489006070
    PMA / PMN Number
    K172763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCTION PROCESS INVESTIGATION: THE BATCH PRODUCTION RECORDS AND FINISHED PRODUCT INSPECTION REPORTS WERE REVIEWED, WITH NO ABNORMALITIES DETECTED DURING PRODUCTION.THE FINISHED PRODUCT TEST RESULTS WERE COMPLIANT.THE PRODUCT WAS ASSEMBLED USING AN AUTOMATIC ASSEMBLY MACHINE, WHICH INCLUDES A BLOCKAGE AND LEAKAGE INSPECTION STEP TO EXAMINE EACH INDIVIDUAL PRODUCT. ANY DEFECTIVE ITEMS ARE AUTOMATICALLY REJECTED.AFTER NEEDLE ASSEMBLY, THE PRODUCT IS TRANSFERRED TO ANOTHER ASSEMBLY MACHINE FOR THE ATTACHMENT OF THE NEEDLE HOLDER. BATCH SAMPLE TESTING: SAMPLE TESTED: BATCH NO. 220916, SPECIFICATION: 0.9*19 RWSB (25 RETAINED SAMPLES OF THE BLOOD COLLECTING NEEDLES). APPEARANCE INSPECTION: NO ABNORMALITIES SUCH AS CRACKING OR CRUSHING WERE OBSERVED ON THE NEEDLE HUB SURFACE. TORQUE FORCE TEST: 5 RETAINED SAMPLES WERE TESTED, AND ALL RESULTS WERE COMPLIANT. LIPID RESISTANCE TEST: 15 RETAINED SAMPLES WERE TESTED USING THREE COMMONLY USED CLINICAL DISINFECTANT SOLUTIONS (ALCOHOL-BASED DISINFECTANT, IODOPHOR DISINFECTANT, AND ISOPROPANOL DISINFECTANT), WITH 5 SAMPLES TESTED PER SOLUTION. NO CRACKING OCCURRED. (REFER TO ATTACHMENT 1 FOR THE RETAINED SAMPLE TEST REPORT.) SIMULATED CLINICAL BLOOD COLLECTION TEST: 5 SAMPLES WERE TESTED, AND NO CRACKING OR DETACHMENT WAS OBSERVED. ROOT CAUSE ANALYSIS: BASED ON THE ABOVE INVESTIGATION, THE PRELIMINARY POSSIBLE CAUSES ARE: DAMAGE DURING TRANSPORTATION: ROUGH HANDLING MAY HAVE CAUSED CRACKING OR DAMAGE TO THE NEEDLE HUB. IMPROPER ASSEMBLY WITH NEEDLE HOLDER: DURING MACHINE SETUP, IF ADJUSTMENTS WERE NOT FULLY OPTIMIZED, THE NEEDLE HUB COULD HAVE BEEN OVER-TIGHTENED AND CRACKED, AND THE DEFECT MAY NOT HAVE BEEN DETECTED AND REJECTED DURING FULL INSPECTION. IMPROPER CLINICAL OPERATION: THE NEEDLE HUB MAY HAVE BEEN ACCIDENTALLY OVER-TIGHTENED OR CRACKED DURING CONNECTION WITH OTHER COMPONENTS IN CLINICAL USE. CHEMICAL REACTION WITH DISINFECTANT SOLUTIONS: THE DISINFECTANT SOLUTIONS USED CLINICALLY MAY HAVE CAUSED A CHEMICAL REACTION LEADING TO NEEDLE HUB CRACKING.

    Description of Event or Problem · 0

    THE LUER LOCK WAS BROKEN WHEN THE USER COLLECTED THE BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2520798 MEDLINE INDUSTRIES,LP LUER LOCK ACCESS DEVICE JKA ZHEJIANG KINDLY MEDICAL DEVICES CO.,LTD 0.9*19RWSB 220916 10193489006070

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown