BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICSAFE MEDICAL GROUP LIMITED

    MDR report key: 23165059 · Received September 29, 2025

    Report

    Report Number
    3003560965-2025-00027
    Event Type
    Malfunction
    Date Received
    September 29, 2025
    Date of Event
    September 15, 2025
    Report Date
    September 29, 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: THE BATCH PRODUCTION RECORD AND FINISHED PRODUCT RELEASE INSPECTION RECORD FOR THE RELEVANT BATCH WERE REVIEWED. NO ABNORMALITIES WERE FOUND DURING THE PRODUCTION PROCESS OR THE FINISHED PRODUCT INSPECTION, AND THE FINISHED PRODUCT RELEASE INSPECTION RESULTS WERE QUALIFIED. 2. RETAINED SAMPLE TESTING: 20 PIECES OF RETAINED SAMPLES FROM BATCH NO.: 240321, SPECIFICATION: 22G*1 1/4'' SAFETY BLOOD COLLECTING NEEDLES WERE SELECTED FOR TESTING: (1) VISUAL INSPECTION: THE SURFACE OF THE RUBBER SLEEVE OF THE SAFETY BLOOD COLLECTING NEEDLES WAS SMOOTH, WITH NO DAMAGE OR PINHOLES OBSERVED. ALL COMPONENTS WERE INTACT AND UNDAMAGED. (2) FIVE PIECES WERE TESTED FOR SAFETY DEVICE ACTIVATION FORCE AND DESTRUCTIVE FORCE. ALL TEST RESULTS MET THE REQUIREMENTS. (3) A TOTAL OF 10 PIECES WERE USED TO SIMULATE CLINICAL USE BY PRESSING WITH THE THUMB AND PRESSING AGAINST A DESKTOP TO ACTIVATE THE SAFETY DEVICE. NO LEAKAGE OR TUBE EJECTION WAS OBSERVED. (4) FIVE PIECES WERE CONNECTED TO A 5KPA WATER PRESSURE SYSTEM TO SIMULATE CLINICAL BLOOD COLLECTION TESTING. EACH BLOOD COLLECTING NEEDLE WAS USED TO COLLECT FIVE VACUUM COLLECTION TUBES, AND NO RUBBER SLEEVE DETACHMENT (LEAKAGE) OCCURRED. 3. ROOT CAUSE ANALYSIS: AS NO SPECIFIC PHYSICAL SAMPLES OR IMAGES WERE RECEIVED FOR INVESTIGATION, A PRELIMINARY ANALYSIS OF POSSIBLE CAUSES IS AS FOLLOWS: (1) RUBBER SLEEVE DETACHMENT (BLOOD LEAKAGE): A. IF THE RUBBER SLEEVE DETACHES BEFORE INSERTING THE COLLECTION TUBE, IT MAY HAVE BEEN PULLED OFF ALONG WITH THE PROTECTIVE SLEEVE WHEN THE PROTECTIVE SLEEVE WAS REMOVED. B. IT MAY BE CAUSED BY IMPROPER OPERATION, SUCH AS FAILURE TO USE THE DEVICE WITH A HOLDER, OR ACCIDENTAL REMOVAL OF THE RUBBER SLEEVE ALONG WITH THE COLLECTION TUBE DURING TUBE REMOVAL. (2) SAFETY MECHANISM FAILURE: A. IT MAY BE DUE TO ROUGH HANDLING DURING TRANSPORTATION AFTER LEAVING THE FACTORY, CAUSING DAMAGE TO THE SAFETY MECHANISM AND PREVENTING THE NEEDLE FROM PROPERLY RETRACTING INTO THE SAFETY MECHANISM. B. IT MAY BE DUE TO NOT PRESSING THE SAFETY MECHANISM STRAIGHT AS REQUIRED IN THE INSTRUCTIONS DURING ACTIVATION. IF FORCE IS APPLIED TO THE SIDE OF THE CAP, THE CAP MAY TILT, PREVENTING THE NEEDLE TIP FROM ENTERING THE CAP.

    Description of Event or Problem · 0

    ALL CONCERNS HAPPENED WHEN NURSES WERE DRAWING PATIENT'S PRE-OP LABS. WHILE STICKING THE PATIENT, THE ADAPTER ATTACHED TO THE NEEDLE WITH RUBBER SLEEVE DETACHED DURING COLLECTION. THIS RESULTED IN STICKING THE PATIENTS AGAIN BECAUSE THE BLOOD WAS NOT FLOWING INTO THE TUBE, BUT TO THE FLOOR. THIS HAPPENED TWICE. A THIRD INCIDENT WAS WHEN THEY WERE ACTIVATING THE SAFETY CAP. WHEN THE NURSE FLIPPED THE CAP TO COVER THE NEEDLE, THE CAP WENT SIDEWAYS, WHICH WAS STILL EXPOSING THE SHARP TIP PART OF THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1839525 MICSAFE MEDICAL GROUP LIMITED SAFETY BLOOD COLLECTING NEEDLES JKA ZHEJIANG KINDLY MEDICAL DEVICES CO.,LTD 22G*1 1/4'' 240321

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown