BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JIANGSU MICSAFE MEDICAL TECHNOLOGY CO.,LTD

    MDR report key: 21477212 · Received February 27, 2025

    Report

    Report Number
    3003560965-2025-00005
    Event Type
    Malfunction
    Date Received
    February 27, 2025
    Report Date
    February 24, 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) SAMPLE RETENTION INSPECTION: ON (B)(6) 2025, 20 SAFETY BLOOD COLLECTION NEEDLE RETENTION PRODUCTS WITH BATCH NUMBER: 220615 SPECIFICATIONS: 22G*1 1/4 WERE SELECTED FOR RELEVANT TESTING AS FOLLOWS: 1. 20 SAFETY BLOOD COLLECTION NEEDLES WERE USED FOR APPEARANCE INSPECTION. THE NEEDLES WERE STRAIGHT WITHOUT BENDING, AND THE SAFETY DEVICES WERE NOT DAMAGED (AS SHOWN BELOW); 2. 10 SAFETY BLOOD COLLECTION NEEDLES WITH RETENTION SAMPLES WERE RANDOMLY USED FOR BLOOD COLLECTION TEST OF SIMULATED CLINICAL ROTATION AND DISPENSING DEVICE (AS SHOWN IN THE VIDEO IN APPENDIX 1 BELOW). THE TEST RESULTS SHOWED THAT THERE WAS NO DIFFICULTY IN ROTATING AND DISPENSING OF THE NEEDLE HOLDER OR LEAKAGE OF THE NEEDLE HOLDER, AND THE SAFETY DEVICES COULD NORMALLY STIMULATE AND SHIELD THE NEEDLE TIP. 3. FIVE SAFETY BLOOD COLLECTION NEEDLES (10 IN TOTAL) WERE USED TO SIMULATE CLINICAL PRACTICE BY PRESSING THE DESKTOP AND THUMB RESPECTIVELY (SEE APPENDIX 2 AND 3 VIDEOS FOR DETAILS). THE BATCH PRODUCTS COULD NORMALLY STIMULATE THE SAFETY DEVICE TO SHIELD THE NEEDLE TIP, AND NO ABNORMAL BREAKAGE OF THE SAFETY DEVICE WAS OBSERVED. (2) PRODUCTION PROCESS REVIEW: ACCORDING TO THE BATCH NUMBER, THE BATCH RECORD AND FINISHED PRODUCT INSPECTION REPORT OF THE PRODUCTION PROCESS OF THIS BATCH OF PRODUCTS WERE TRACED BACK, AND NO ABNORMALITIES WERE FOUND IN THE PRODUCTION PROCESS AND FINISHED PRODUCT INSPECTION PROCESS, AND THE PRODUCTION PROCESS AND RAW MATERIALS WERE NOT CHANGED.

    Description of Event or Problem · 0

    1.THE SCREW UNDER THE SAFETY BLOOD COLLECTION NEEDLE(PEN TYPE) IS NOT EASY TO USE WHEN IT IS MATCHED WITH THE NEEDLE HOLDER; LEAKAGE OCCURRED WHEN THE RUBBER SLEEVE END OF SAFETY PEN HOLDER WAS CONNECTED TO THE BLOOD VESSEL. 2.THE SAFETY PROTECTIVE CAP WAS BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594562 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