BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECTON,DICKINSON AND COMPANY

    MDR report key: 24629240 · Received March 18, 2026

    Report

    Report Number
    3003560965-2026-00003
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    February 25, 2026
    Report Date
    March 16, 2026
    Manufacturer
    ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.
    Product Code
    JKA
    PMA / PMN Number
    K172763
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1.PRODUCTION PROCESS INVESTIGATION: THE BATCH RECORDS OF THE PRODUCTION PROCESS AND FINISHED PRODUCT RELEASE INSPECTION REPORTS FOR THE ABOVE 3 BATCHES WERE REVIEWED. NO ABNORMALITIES WERE FOUND DURING THE PRODUCTION PROCESS. THE RAW MATERIALS, PRODUCTION FLOW AND PROCESS REMAINED UNCHANGED, AND THE FINISHED PRODUCT INSPECTION RESULTS WERE QUALIFIED. 2.BATCH SAMPLE TESTING:15 SAMPLES EACH (TOTAL 45 PIECES) WERE TAKEN FROM THE RETAINED SAMPLES OF THE BLOOD COLLECTION NEEDLES WITH SPECIFICATION 0.9 19 UNDER BATCH NUMBERS 25101001 / 25092501 / 25090501 FOR TESTING: 1). VISUAL INSPECTION: NO ABNORMALITIES SUCH AS CRACKING OR CRUSHING WERE OBSERVED ON THE HUB SURFACE. 2). CLINICAL BLOOD COLLECTION SIMULATION WAS PERFORMED USING 5 PIECES, AND NO ABNORMALITIES OR FLUID LEAKAGE WERE FOUND DURING THE TEST. 3).15 SAMPLES WERE TAKEN FOR LIPID RESISTANCE TESTING. THREE CLINICALLY COMMONLY USED DISINFECTION SOLUTIONS (ALCOHOL DISINFECTION SOLUTION, POVIDONE IODINE DISINFECTION SOLUTION AND ISOPROPYL ALCOHOL DISINFECTION SOLUTION) WERE TESTED SEPARATELY WITH 5 PIECES OF BLOOD COLLECTION NEEDLES EACH, AND NO CRACKING OCCURRED. 5 RETAINED SAMPLES WERE TAKEN FOR TORQUE FORCE TESTING, AND ALL RESULTS WERE QUALIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THEY GOT A REPORT OF A MBC6010 VACUTAINER BREAKING OFF IN A CVC. HOWEVER, THE CUSTOMER DETERMINED THAT THE CVC CAUSED THE BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601820 BECTON,DICKINSON AND COMPANY BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK JKA ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. 0.9*19 25101001/25092501/250905 01

    Patients

    Seq Age Sex Outcome Treatment
    1