BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD COLLECTION NEEDLE

    MDR report key: 20153892 · Received September 5, 2024

    Report

    Report Number
    3003560965-2024-00071
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    July 4, 2024
    Report Date
    September 4, 2024
    Manufacturer
    ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIVING FEEDBACK FROM CUSTOMERS REGARDING THE COMPLAINED PROBLEM, OUR COMPANY IMMEDIATELY ORGANIZED QUALITY CONTROL, PRODUCTION, AND OTHER RELEVANT PERSONNEL TO INVESTIGATE AND ANALYZE THE SITUATION. THE SPECIFIC DETAILS ARE AS FOLLOWS: 1. CHECK THE APPEARANCE OF NEEDLE TIPS: RANDOMLY SELECT 5 PCS (10PCS IN TOTAL) SAFETY BLOOD-COLLECTING NEEDLES FROM THE ABOVE TWO BATCHES, AND PLACE THE NEEDLE TIPS UNDER 28X MAGNIFICATION FOR INSPECTION. THE NEEDLE TIPS ARE SHARP AND HAVE NO ROUGH EDGES, BURRS OR HOOKS, ETC. TWO BATCHES OF NEEDLE TIP INSPECTION RESULTS: ALL QUALIFIED, NO BURRS, FOREIGN BODIES WERE FOUND. (2) PRODUCTION PROCESS REVIEW: ACCORDING TO THE BATCH NUMBER, TRACE THE BATCH RECORDS OF THE PRODUCTION PROCESS OF THE BATCH OF PRODUCTS AND THE FINISHED PRODUCT INSPECTION REPORT, NO ABNORMAL PHENOMENON WAS FOUND, AND THE RAW MATERIALS AND PRODUCTION PROCESS OF THE BATCH OF PRODUCTS WERE BOTH NO CHANGE WAS FOUND. (3) RETEST OF SENT-BACK SAMPLES: THE REAL SAMPLES RECEIVED FROM THE CUSTOMER ON (B)(6) 2024, SPECIFICATIONS AND MODELS: 21G×1 1/4 "/22G×1 1/4" LOT NUMBER: 240514 A TOTAL OF 18 DEFECTIVE (ALREADY (OPENED) SAFETY BLOOD-COLLECTING NEEDLES, IMMEDIATELY ARRANGE FOR RE-INSPECTION, 2. BURRS AND HOOK PHENOMENON. THE AMPLIFIED OBSERVATION OF THE BURR OF THE NEEDLE TIP OF THE SAMPLE WAS FOUND THAT A NEEDLE TIP DID HAVE A RELATIVELY OBVIOUS HOOK SITUATION, AND THE FOLLOWING FACTORS MAY CAUSE THE NEEDLE TIP DAMAGED TO FORM BURRS: 3. FOREIGN MATTER PROBLEM. AFTER OBSERVATION AND COMPARISON OF THE RETURNED SAMPLES, THE FOREIGN MATTER IS THE RAW MATERIAL INJECTION FLOWS IN THE PRODUCTION PROCESS, WHICH IS CAUSED BY THE FAILURE TO WIPE THE INJECTION MOLD. PRELIMINARY ANALYSIS OF THIS INCIDENT MAY BE CAUSED BY THE IMPACT OF THE INSPECTION ENVIRONMENT, NOT CAUSED BY PRODUCT QUALITY PROBLEMS.

    Description of Event or Problem · 0

    THE CUSTOMER COMPLAINED THAT THERE WERE BURRS AND FOREIGN BODIES IN TWO SPECIFICATIONS OF PRODUCTS, THE SPECIFIC SAMPLING INSPECTION IS AS FOLLOWS: SAMPLING QUANTITY PER SPECIFICATION: 13 PCS/FIRST SAMPLING, 13 PCS/ SECOND SAMPLING, 26 PCS/THIRD SAMPLING. 21G: 23%/FIRST SAMPLING, 7.69%/SECOND SAMPLING, 7.69%/THIRD SAMPLING. 22G: 15.38%/FIRST SAMPLING, 0%/SECOND SAMPLING, 3.84%/THIRD SAMPLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2035876 BLOOD COLLECTION NEEDLE BLOOD COLLECTION NEEDLE JKA ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. 21G×1 1/4", 22G×1 1/4" 240514

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown