BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELI

    MDR report key: 19709360 · Received July 10, 2024

    Report

    Report Number
    3003560965-2024-00064
    Event Type
    Malfunction
    Date Received
    July 10, 2024
    Report Date
    July 10, 2024
    Manufacturer
    ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.
    Product Code
    JKA
    UDI-DI
    10386120009350
    PMA / PMN Number
    K172763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIVING CUSTOMER FEEDBACK REGARDING THE "CUSTOMER COMPLAINT THE QUALITY PROBLEM OF BLOOD COLLECTION TUBE, ADAPTERS, RUBBER SLEEVE AND PROTECTIVE COVER OF SAFETY BLOOD COLLECTING NEEDLE" OUR COMPANY PROMPTLY ORGANIZED QUALITY CONTROL, PRODUCTION, AND RELATED PERSONNEL TO INVESTIGATE THE SITUATION. SPECIFIC DETAILS ARE AS FOLLOWS: (1) PRODUCTION PROCESS REVIEW: UPON INSPECTION OF THE PRODUCTION RECORDS OF THIS BATCH OF PRODUCTS, THERE WERE NO ABNORMALITIES IN THE PRODUCTION PROCESS, AND THERE WERE NO CHANGES IN THE RAW MATERIALS AND PRODUCTION PROCESSES OF THE PRODUCTS. (2) RETAINED SAMPLE TESTING: ON MAY 22,2024, 25 SAMPLES WERE EXTRACTED FOR BATCH NUMBER: 240321, SPECIFICATION: 22G×1 1/4". 10 OF THESE SAMPLES WERE INSPECTING THE APPEARANCE, AND THE NEEDLE TUBES WERE STRAIGHT WITHOUT BENDING, AND THE SAFETY DEVICES WERE NOT DAMAGED. RANDOMLY SIMULATED CLINICAL BLOOD SAMPLING WITH 5 SAMPLES AFTER USE SAFETY DEVICE TESTING, THE 10 SAMPLE MENTIONED BEFORE CONDUCTING THE EXCITING FORCE AND DESTRUCTIVE TESTING, ANOTHER 5 (10 IN TOTAL) WERE EXTRACTED TO SIMULATE CLINICAL STIMULATION USING DESKTOP PRESSING AND THUMB PRESSING RESPECTIVELY. (3) ROOT CAUSE ANALYSIS: BASED ON CUSTOMER FEEDBACK, ANALYZING THE PRODUCTION AND MANUFACTURING PROCESSES OF BLOOD COLLECTION NEEDLE PRODUCTS, IT IS SPECULATED THAT THE PHENOMENON OF TUBE BREAKAGE IS CAUSED BY THE LUBRICATION OF THE NEEDLE END OF THE BLOOD COLLECTION NEEDLE PRODUCT AND THE WRAPPING FORCE OF THE RUBBER PLUG. AND IT WAS SPECULATED THAT THE DIMENSIONAL TOLERANCE OF THREAD OF BLOOD COLLECTION NEEDLE AND THE THREAD OF THE NEEDLE HOLDER LED TO COMPATIBILITY ISSUES. THE REMOVAL OF PROTECTIVE COVERS AND DEFORMATION OF SAFETY DEVICES MAKE IT IMPOSSIBLE TO PROTECT. DUE TO SEVERE HANDLING DURING TRANSPORTATION/LOADING, THE SAFETY DEVICE ARM HAS BEEN DAMAGED. FURTHER INVESTIGATION IS NEEDED TO UNDERSTAND THE SPECIFIC CAUSE OF THE PROBLEMS OF NEEDLE. WE RECOMMEND THE CUSTOMER TO ASSIST BY COLLECTING AND SENDING BACK THE ABNORMAL ACTIVATION OF RELEVANT SAFETY DEVICES FOR FURTHER ANALYSIS.

    Description of Event or Problem · 0

    8 TEAMMATES COMMENTS THAT THE "TUBES POP" OFF AND WHEN REAPPLYING TUBES ARE NOT FILLING PROPERLY. 4 TEAMMATES COMMENTS THAT THE DEVICE IS DIFFICULT TO SCREW ONTO THE ADAPTERS THAT IT CROSS THREADS. 3 TEAMMATES THAT THEY HAVE HAD THE SAFETY FEATURECOMPLETELY BREAK OFF WHEN APPLYING ONTO THE HUB·MULTIPLE TEAM HAVE SAID THE NEEDLES ONCE SET UP THEY HAVE HAD DIFFICULTYREMOVING THE CAP TO EXPOSE THE COLLECTION NEEDLE ·2 HAVE HAD THE RUBBER THAT CLOSES OFF THE BLOOD FROM ENTERING THE TUBECOME OFF OR PARTIALLY COME OFF DURING COLLECTION RESULTING IN BLOOD SPILLAGE. " DEVICE SEEMS MORE BULKIER, AND CUMBERSOMEBECAUSE THE SAFETY SHIELD GETS IN THE WAY AND WHEN REPOSITIONED THE SAFETY FEATURE BECOMES WEAKENED AND HAS BROKEN " "HAVE HAD SOME THAT THE SAFETY GUARD WERE ALREADY DISLODGED PRIOR TO SET UP" "SAFETY DEVICE HAD NOT CLOSED PROPERLY SEVERALTIMES, CONCERNED ABOUT GETTING ACCIDENTLY STUCK"·"SAFETY SHIED DOES NOT OPEN FULLY TO VIEW COLLECTION SITE PRECISELY"·WE RECENTLY HAD A LONG-TIME EMPLOYEE HAVE AN ACCIDENTAL DIRTY NEEDLE STICK DUE TO SAFETY SHIELD WOULD NOT OPEN FULLY FOR VIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977455 RELI SAFETY BLOOD COLLECTION NEEDLE JKA ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. 240321 10386120009350

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown