BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JIANGSU MICSAFE MEDICAL TECHNOLOGY CO.,LTD

    MDR report key: 23106714 · Received September 22, 2025

    Report

    Report Number
    3003560965-2025-00023
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    August 29, 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: CHECK THE PRODUCTION RECORDS OF THIS BATCH OF PRODUCTS, AND THERE ARE NO ABNORMALITIES IN THE PRODUCTION PROCESS. THE RAW MATERIALS AND PRODUCTION PROCESSES OF THE PRODUCTS HAVE NOT CHANGED, AND ANALYZE THE FOLLOWING FACTORS: PERSON: THE PRODUCT IS PRODUCED USING AN AUTOMATIC ASSEMBLY MACHINE, AND THE NEEDLE BENDING PHENOMENON IS NOT RELATED TO PERSONNEL. THE PERSONNEL HAVE BEEN TRAINED AND ASSESSED TO BE QUALIFIED FOR THE JOB, BUT IT CANNOT BE RULED OUT THAT DUE TO WORK NEGLIGENCE, THE DEFECTIVE PHENOMENON WAS NOT DETECTED IN A TIMELY MANNER. MACHINE: THIS PRODUCT IS PRODUCED USING AN AUTOMATIC ASSEMBLY MACHINE, WHICH UNDERGOES DAILY INSPECTIONS AND REGULAR MAINTENANCE. BASED ON THE IMAGES PROVIDED BY THE CUSTOMER, IT CANNOT BE RULED OUT THAT EXTERNAL FORCES APPLIED BY THE EQUIPMENT DURING THE PRODUCTION PROCESS MAY HAVE CAUSED THE NEEDLE TUBE TO BEND. MATERIAL: THE NEEDLE TUBE MATERIAL UNDERGOES RIGIDITY INSPECTION BEFORE PROCESSING AND CAN ONLY BE USED AFTER PASSING THE INSPECTION. IF THE MATERIAL IS THE CAUSE, IT SHOULD BE BATCH NONCONFORMITY, SO THIS FACTOR CAN BE RULED OUT. METHOD: IF THE PRODUCTION PROCESS HAS NOT CHANGED, THIS FACTOR CAN BE RULED OUT. ENVIRONMENT: THIS PHENOMENON IS NOT RELATED TO THE ENVIRONMENT AND THE PRODUCT IS PRODUCED IN A CLEAN WORKSHOP. 2. SAMPLE RETENTION TESTING: EXTRACT BATCH NUMBER: 240514 SPECIFICATION: 21G *1 1/4'' SAMPLE RETENTION SAFETY BLOOD COLLECTING NEEDLE 10 FOR TESTING: 1) THE APPEARANCE INSPECTION OF THE SAFE BLOOD COLLECTING NEEDLE SHOWS THAT THE NEEDLE TUBE IS STRAIGHT AND WITHOUT BENDING. 2) USING 10 SAFE BLOOD COLLECTING NEEDLES IN COMBINATION WITH THE NEEDLE HOLDER PROVIDED BY THE CUSTOMER, SIMULATED CLINICAL BLOOD COLLECTION TESTS WERE CONDUCTED WITHOUT ANY ABNORMAL PHENOMENON. 3. CAUSE ANALYSIS: BASED ON THE ABOVE INVESTIGATION AND ANALYSIS, COMBINED WITH CUSTOMER FEEDBACK DIAGRAMS AND ANALYSIS OF THE PRODUCTION PROCESS AND TECHNOLOGY OF BLOOD COLLECTING NEEDLES, THIS INCIDENT WAS CAUSED BY SOME MACHINE CLAW SCREWS LOOSENING AND THE MACHINE CLAW GROOVE SHIFTING, RESULTING IN THE MACHINE CLAW NOT GRIPPING THE BLOOD COLLECTING NEEDLE IN THE GROOVE, AND THE NEEDLE TIP ALSO BENDING AND DEFORMING DUE TO EXTERNAL FORCE FROM THE MACHINE CLAW; THE FAILURE OF THE FULL INSPECTION WORK TO DETECT AND ELIMINATE DEFECTIVE PRODUCTS IN A TIMELY MANNER RESULTED IN THE OUTFLOW OF DEFECTIVE PRODUCTS; THE SALES QUANTITY OF THIS BATCH OF BLOOD COLLECTING NEEDLES IS (B)(4), AND THIS IS THE FIRST TIME THIS ISSUE HAS BEEN REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER FOUND THAT A PRODUCT HAD BENT BEFORE USE, AS SHOWN IN THE PICTURE. PLEASE INVESTIGATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2700242 JIANGSU MICSAFE MEDICAL TECHNOLOGY CO.,LTD BLOOD COLLECTION NEEDLES JKA ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. 21G*1 1/4'' 240514

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown