BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERIC MEDICAL LLC

    MDR report key: 19474501 · Received June 6, 2024

    Report

    Report Number
    3003560965-2024-00036
    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 FEEDBACK FROM CUSTOMERS REGARDING THE "BLOOD CULTURE BLOOD COLLECTION NEEDLE LEAKING BLOOD DURING USE," WE IMMEDIATELY ORGANIZED QUALITY CONTROL, PRODUCTION, AND OTHER RELEVANT PERSONNEL TO INVESTIGATE AND ANALYZE THE SITUATION. THE SPECIFIC DETAILS ARE AS FOLLOWS: BATCH TESTING: SINCE THE CUSTOMER DID NOT PROVIDE RELATED BATCH INFORMATION THIS TIME, LOT: 221210 WAS SELECTED FOR SAMPLING TESTING WITH A SPECIFICATION OF 0.9*19. TEN SAMPLES FROM THIS BATCH WERE VISUALLY INSPECTED, AND 6% LUER CONNECTORS SHOWED NO DAMAGE OR ANOMALIES. FIVE SAMPLES UNDERWENT TORQUE TESTING (WITH A REQUIREMENT OF TORQUE FORCE 0.70NM), AS SHOWN IN THE TABLE BELOW; ANOTHER FIVE SAMPLES WERE USED FOR SIMULATED CLINICAL BLOOD COLLECTION, SUCCESSFULLY TRANSFERRING BLOOD WITHOUT LEAKAGE. BASED ON THE COMPREHENSIVE INVESTIGATION RESULTS, ALL TEST OUTCOMES MET THE PRODUCT STANDARD REQUIREMENTS. ACCORDING TO CUSTOMER FEEDBACK, THERE WAS NO CONTINUOUS BLOOD LEAKAGE DURING THE INITIAL BLOOD COLLECTION PROCESS; THEREFORE, WE CONCLUDE THAT THE PRODUCT ITSELF IS NORMAL. FURTHERMORE, CONSIDERING THE PRODUCTION PROCESS, TECHNOLOGY, AND CHARACTERISTICS OF THE BLOOD CULTURE BLOOD COLLECTION NEEDLE, WE PRELIMINARILY ANALYZED THE POSSIBLE CAUSES OF LEAKAGE, INCLUDING: 1. EXCESSIVE TWISTING FORCE DURING USE, EXCEEDING THE NORMAL TORQUE FORCE REQUIREMENT IN OUR TESTING, LEADING TO CRACKING OR DAMAGE OF THE NEEDLE HOLDER CAUSING FLUID LEAKAGE AT THE CONE CONNECTION; 2. INADEQUATE TIGHTENING OF THE THREADS, CAUSING LOOSENING DURING THE REPLACEMENT OF THE SECOND COLLECTION TUBE, RESULTING IN POSSIBLE BLOOD LEAKAGE DUE TO POOR FIT; 3. THE BLOOD CULTURE BLOOD COLLECTION NEEDLE IS MADE OF NON-RESISTANT ABS MATERIAL, WHICH MAY BE DAMAGED BY CONTACT WITH DISINFECTANTS. IT IS POSSIBLE THAT RESIDUAL DISINFECTANT ON THE HANDS OF MEDICAL STAFF COULD COME INTO CONTACT WITH THE CONE HEAD, CAUSING IT TO CRACK.

    Description of Event or Problem · 0

    AFTER THE NURSE FILLS THE FIRST PLASMA COLLECTION BOTTLE USING A PLASMA TRANSFER DEVICE, WHEN TRANSFERRING THE SYRINGE TO THE SECOND PLASMA COLLECTION BOTTLE FOR PLASMA COLLECTION, THE PLASMA DOES NOT FLOW SMOOTHLY AND BUBBLES UP, TAKING A LONG TIME. IF THE NURSE TRIES TO SPEED UP BY PUSHING THE SYRINGE, THE EDGES OF THE PLASMA TRANSFER DEVICE MAY BURST OPEN ON THEIR OWN, SOMETIMES CAUSING BLOOD TO SPRAY OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1862808 MAVERIC MEDICAL LLC BLOOD COLLECTION NEEDLE JKA ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. 20G×19MM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown