BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 19493118 · Received June 8, 2024

    Report

    Report Number
    3003560965-2024-00061
    Event Type
    Malfunction
    Date Received
    June 8, 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

    BASED ON THE USER FEEDBACK STATING "CUSTOMER COMPLAINED THAT AFTER USING THE PRODUCT WITH A SYRINGE, THE NEEDLE BROKE INSIDE THE BODY. PLEASE INVESTIGATE! AS THE CUSTOMER DID NOT PROVIDE THE BATCH NUMBER, PLEASE INVESTIGATE THE LATEST THREE BATCH NUMBERS: 231005, 231025, 231120," THE FACTORY'S INITIAL ANALYSIS SUGGESTS THAT THE ISSUE MIGHT BE DUE TO EITHER NO ADHESIVE BETWEEN THE NEEDLE HUB AND THE NEEDLE OR INSUFFICIENT BONDING STRENGTH. THE FOLLOWING INVESTIGATION WAS CONDUCTED REGARDING THE POTENTIAL CAUSES: 1. SAMPLE TESTING: ON DECEMBER 13, 2023, FOR BATCH NUMBERS 231005, 231025, AND 231120 WITH THE SPECIFICATION MODEL 25G??1 1/2", 20 SAMPLES FROM EACH BATCH WERE IMMEDIATELY TESTED FOR VISUAL INSPECTION, RIGIDITY, TOUGHNESS, AND BONDING STRENGTH. RE-TESTS ACCORDING TO ISO 7864 SHOWED THAT ALL SAMPLES HAD ADHESIVE PRESENT AND ADEQUATELY FILLED BETWEEN THE NEEDLE AND HUB, WITH NO DEFECTS ON THE NEEDLE SURFACE. IN LOAD TESTING, THE STANDARD SPECIFIES THAT THE NEEDLE HUB AND NEEDLE SHOULD NOT SEPARATE UNDER A FORCE OF 22N, AND IN ALL THESE BATCHES, THE NEEDLES DID NOT SEPARATE. ACCORDING TO ISO 7864:2016 AND ISO 9626:2016 FOR TOUGHNESS TESTING, WHERE THIN-WALLED NEEDLES ARE BENT (20??1)?? AND SHOULD NOT BREAK AFTER 20 FLEX CYCLES, 10 SAMPLES FROM EACH BATCH WERE TESTED AND FOUND TO BE COMPLIANT. 2. PRODUCTION PROCESS REVIEW: REVIEWING THE PRODUCTION RECORDS AND FACTORY INSPECTION REPORTS FOR THESE BATCHES SHOWED THAT ADHESIVE WAS PROPERLY APPLIED, AND BOND STRENGTH MET REQUIREMENTS DURING PRODUCTION. THE FACTORY INSPECTION REPORTS ALSO CONFIRMED THAT THE BONDING STRENGTH WAS WITHIN THE ACCEPTABLE RANGE. 3. PRODUCTION SITE REVIEW: A TRACEABILITY REVIEW OF THE AUTOMATED MACHINES USED TO PRODUCE THESE BATCHES SHOWED THAT REAL-TIME ONLINE DETECTION ENSURED ADHESIVE WAS PROPERLY APPLIED AND SUBSTANDARD PRODUCTS WERE REJECTED. THE ADHESIVE APPLICATION WAS CONSISTENT AND MET THE REQUIRED STANDARDS. BASED ON THE SAMPLE CHECKS, PRODUCTION PROCESS INSPECTION RECORDS, FACTORY INSPECTION RECORDS, AND PRODUCTION SITE REVIEWS, THESE THREE BATCHES MET ALL BONDING STRENGTH, RIGIDITY, AND TOUGHNESS REQUIREMENTS AND DID NOT SHOW THE REPORTED PROBLEMS. OUR PRELIMINARY ANALYSIS OF THE NEEDLE DETACHMENT ISSUE BASED ON CUSTOMER FEEDBACK IS AS FOLLOWS: 1. NEEDLE BREAKAGE DURING USE: THE NEEDLE MAY BREAK DUE TO IMPROPER USE. ACCORDING TO ISO 7864:2016 AND ISO 9626:2016 REQUIREMENTS FOR BENDING, NORMAL WALL NEEDLES CAN BEND (25±1)°, THIN-WALLED NEEDLES (20±1)°, AND ULTRA-THIN-WALLED NEEDLES (15±1)° WITHOUT BREAKING AFTER 20 BENDS. EXCEEDING THESE STANDARDS INCREASES THE LIKELIHOOD OF BREAKAGE. ALTHOUGH THE USERS ARE USUALLY PROFESSIONALLY TRAINED HEALTHCARE WORKERS, IMPROPER USE CANNOT BE ENTIRELY RULED OUT. 2. INSUFFICIENT ADHESIVE LEADING TO DETACHMENT: DURING ASSEMBLY, ONLINE DETECTION DEVICES ENSURE ADEQUATE ADHESIVE APPLICATION. SUBSTANDARD PRODUCTS WITHOUT ADHESIVE ARE AUTOMATICALLY REMOVED. INITIAL AND RANDOM CHECKS ADDITIONALLY CONFIRM BONDING STRENGTH, MAKING THIS SCENARIO HIGHLY UNLIKELY. AFTER RECEIVING THE COMPLAINT, WE PROACTIVELY INVESTIGATED BUT COULD NOT PROCEED FURTHER AS THE CUSTOMER DID NOT PROVIDE DEFECTIVE SAMPLES OR IMAGES. WE SUGGEST THAT THE CUSTOMER COLLECT THE DEFECTIVE SAMPLE AND SEND IT BACK OR PROVIDE HIGH-RESOLUTION IMAGES OF THE SEPARATION AREA (FOCUSING ON THE BREAK POINT) TO HELP US DETERMINE WHETHER THE ISSUE IS DUE TO ADHESIVE FAILURE OR EXTERNAL FORCE, AIDING FURTHER ANALYSIS AND CONFIRMATION.

    Description of Event or Problem · 0

    A CUSTOMER COMPLAINED THAT AFTER USING THE PRODUCT WITH A SYRINGE, THE NEEDLE BROKE INSIDE THE PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031287 MEDLINE NEEDLE FMI SHANGHAI KINDLY ENTERPRISEDEVELOPMENTGROUP CO.,LTD 25G×1 1/2"

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown