BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 19492961 · Received June 7, 2024

    Report

    Report Number
    3003560965-2024-00059
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Report Date
    May 31, 2024
    Manufacturer
    SHANGHAI KINDLY ENTERPRISEDEVELOPMENTGROUP CO.,LTD
    Product Code
    FMI
    PMA / PMN Number
    K112057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIVING CUSTOMER FEEDBACK REGARDING THE BROKEN SYRINGE NEEDLE DURING THE USE OF THE MEILIAN BULK INJECTION NEEDLES, WITH NO IMAGES OR BATCH NUMBERS PROVIDED AT THE MOMENT, WE HAVE INITIATED AN IMMEDIATE INVESTIGATION. HERE ARE THE SPECIFIC ACTIONS TAKEN: 1. SAMPLE RETESTING: ON NOVEMBER 14, 2023, SAMPLES FROM BATCH NUMBERS 230730, 230712, AND 230725 OF THE 25G×1 1/2" BULK NEEDLES WERE VISUALLY INSPECTED WITH ADHESIVE INTEGRITY TESTING, AS WELL AS RIGIDITY AND TOUGHNESS TESTS (REFER TO IMAGES). ALL TESTS ON 30 SAMPLES FROM THESE BATCHES CONFIRMED NO ABNORMALITIES, FRACTURES, OR ISSUES WITH NEEDLE SEAT AND BARREL BREAKAGE. TESTING CONDUCTED WITH MEDICAL INJECTION NEEDLE RIGIDITY AND TOUGHNESS TESTERS. PERSONNEL INVOLVED: SONG WENXIU. 2. PRODUCTION PROCESS REVIEW: THE PRODUCTION RECORDS AND OUTGOING INSPECTION REPORTS FOR THE MENTIONED BATCH NUMBERS CONFIRMED THE ADHESIVE INTEGRITY, RIGIDITY, AND TOUGHNESS OF THE INJECTION NEEDLE PRODUCTS MEETING STANDARD REQUIREMENTS. NO ALTERATIONS WERE FOUND IN THE PRODUCTION PROCESS OR MATERIALS USED. BASED ON THE INVESTIGATION RESULTS, CUSTOMER FEEDBACK, AND ANALYSIS OF THE NEEDLE PRODUCTION PROCESS, THE FOLLOWING ASSESSMENTS WERE MADE: 1. NEEDLE BREAKAGE DURING USE: IMPROPER USAGE CAN LEAD TO NEEDLE BREAKAGE. ACCORDING TO ISO STANDARDS, CONTINUOUS BENDING BEYOND THE SPECIFIED LIMITS CAN INCREASE THE RISK OF BREAKAGE. DESPITE PROPER TRAINING OF HEALTHCARE PROFESSIONALS, MISUSE MAY STILL OCCUR. 2. INSUFFICIENT ADHESIVE BETWEEN THE NEEDLE BARREL AND SEAT: ASSEMBLY PROCESSES INCLUDE AUTOMATED CHECKS FOR ADHESIVE QUANTITY, GREATLY REDUCING THE CHANCES OF SEPARATION. THE POSSIBILITY OF DETACHMENT DUE TO INSUFFICIENT ADHESIVE IS MINIMAL. AS THE CUSTOMER'S PROVIDED IMAGES DID NOT CONCLUSIVELY MATCH OUR PRODUCTS, WE REQUESTED MORE DETAILED INFORMATION, SUCH AS BATCH NUMBERS, ASSOCIATED WITH THE FAULTY PRODUCT IN THE IMAGES FOR FURTHER ANALYSIS.

    Description of Event or Problem · 0

    DURING THE USE OF THE MEDLINE BULK INJECTION NEEDLE, THE SYRINGE NEEDLE BROKE. CURRENTLY, THERE ARE NO PICTURES OR BATCH NUMBERS AVAILABLE FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265616 MEDLINE NEEDLE FMI SHANGHAI KINDLY ENTERPRISEDEVELOPMENTGROUP CO.,LTD 25G×1 1/2"

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown