BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES,LP

    MDR report key: 22912007 · Received August 28, 2025

    Report

    Report Number
    3003560965-2025-00022
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    July 25, 2025
    Report Date
    August 28, 2025
    Manufacturer
    ZHEJIANG KINDLY MEDICAL DEVICES CO.,LTD
    Product Code
    FMI
    UDI-DI
    30080196305531
    PMA / PMN Number
    K112057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1. PRODUCTION PROCESS REVIEW: THE PRODUCTION RECORDS OF THE BATCH WERE EXAMINED, AND NO ABNORMALITIES WERE FOUND IN THE PRODUCTION PROCESS. THE RAW MATERIALS AND MANUFACTURING PROCEDURES REMAINED UNCHANGED, AND THE FINISHED PRODUCTS PASSED THE FACTORY INSPECTION. THE PRODUCT IS ASSEMBLED USING AN AUTOMATIC ASSEMBLY MACHINE, WHICH APPLIES ADHESIVE TO THE NEEDLE TUBES AUTOMATICALLY. THE ASSEMBLY MACHINE IS EQUIPPED WITH A DETECTION DEVICE TO MONITOR THE ADHESIVE APPLICATION, ENABLING REAL-TIME REJECTION OF PRODUCTS WITH INSUFFICIENT ADHESIVE. DURING PRODUCTION, THE ADHESIVE STRENGTH IS INSPECTED AT THE BEGINNING OF EACH SHIFT. 2. BATCH SAMPLE INSPECTION: A SAMPLE OF 10 RETAINED UNITS FROM BATCH NUMBER: 240520 (SPECIFICATION: 22G*1.5'') WAS TESTED AS FOLLOWS: VISUAL INSPECTION: THE ADHESIVE BETWEEN ALL NEEDLE TUBES AND HUBS APPEARED FULLY APPLIED WITH NO ABNORMALITIES. 5 PCS WERE TESTED FOR ADHESIVE STRENGTH BETWEEN THE NEEDLE HUB AND TUBE ACCORDING TO ISO 7864:2016, WITH NO INSTANCES OF DETACHMENT OBSERVED. ANOTHER 5 PCS UNDERWENT SIMULATED CLINICAL INJECTION TESTING, AND NO NEEDLE TUBE DISLODGEMENT OCCURRED. 3. ROOT CAUSE ANALYSIS: BASED ON THE ABOVE INVESTIGATION, THE POSSIBLE CAUSE IS INSUFFICIENT ADHESIVE LEADING TO WEAK BONDING. HOWEVER, SINCE NO DEFECTIVE SAMPLES, RELATED PHOTOS, OR VIDEOS WERE PROVIDED, THE EXACT ROOT CAUSE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT WHEN USING OUR 22G NEEDLES CONNECTED TO A BD 30ML SYRINGE, THE NEEDLE RETRACTED INTO THE HUB DURING USE. THE ISSUE MAY BE RELATED TO BONDING, THE NEEDLE MIGHT NOT HAVE BEEN SECURELY BONDED, CAUSING IT TO RETRACT WHEN SUBJECTED TO FORWARD FORCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1834148 MEDLINE INDUSTRIES,LP HYPODERMIC NEEDLE FMI ZHEJIANG KINDLY MEDICAL DEVICES CO.,LTD 22G*1.5'' 240520 30080196305531

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown