BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERIC MEDICAL LLC

    MDR report key: 19474500 · Received June 6, 2024

    Report

    Report Number
    3003560965-2024-00033
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Report Date
    May 26, 2024
    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

    UPON RECEIVING CUSTOMER FEEDBACK REGARDING THE "BLOOD CULTURE BLOOD COLLECTION NEEDLE ADAPTER DAMAGE LEADING TO BLOOD LEAKAGE" ISSUE, OUR COMPANY IMMEDIATELY ORGANIZED QUALITY CONTROL, PRODUCTION, AND OTHER RELEVANT PERSONNEL TO INVESTIGATE AND ANALYZE THE SITUATION. THE SPECIFIC DETAILS ARE AS FOLLOWS: (1) BATCH SAMPLE TESTING: BASED ON THE CUSTOMER FEEDBACK, 20 SAMPLES FROM THE BATCH WERE TAKEN FOR VISUAL INSPECTION OF THE EXTERNAL APPEARANCE OF THE BLOOD COLLECTION NEEDLE ADAPTER. NO DAMAGE OR DEFECTS WERE FOUND IN THE CONE ADAPTER. ADDITIONALLY, TORQUE FORCE TESTING WAS CONDUCTED ON 5 SAMPLES, APPLYING A TORQUE OF AT LEAST 0.63NM (5.58IN-IBSR) ON THE NEEDLE SEAT OF THE BLOOD COLLECTION NEEDLE TO ENSURE IT DID NOT FRACTURE OR SEPARATE. SEE SPECIFIC TEST RESULTS IN THE TABLE BELOW: (2) PRODUCTION PROCESS REVIEW: THE PRODUCTION PROCESS BATCH RECORDS AND FINISHED PRODUCT INSPECTION REPORTS FOR THIS BATCH WERE TRACED BACK. NO ABNORMALITIES WERE FOUND DURING THE PRODUCTION AND QUALITY INSPECTION PROCESSES.

    Description of Event or Problem · 0

    CUSTOMERS REPORTED THAT THE TIP OF THE BLOOD COLLECITON NEEDLE WAS BROKEN DURING TRANSFER BLOOD CULTURE, CAUSING BLOOD SPILLAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1862807 MAVERIC MEDICAL LLC BLOOD COLLECTION TUBE JKA ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. 20G×19MM 220615

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown