BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHIFENG SAFETY NEEDLE

    MDR report key: 17269712 · Received July 5, 2023

    Report

    Report Number
    MW5119153
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Date of Event
    June 15, 2023
    Report Date
    July 3, 2023
    Manufacturer
    CHENGDU SHIFENG MEDICAL TECHNOLOGY CO.,LTD
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SAFETY NEEDLE IS NOT ENGAGING PROPERLY. CAUSED A NEEDLE STICK INJURY TO OCCUR. MULTIPLE PRODUCTS WITH THE SAME MANUFACTURE/LOT NUMBER HAD THIS PROBLEM. THE NEEDLE USED: SIZE: 25 GAUGE, 1.5-INCH NEEDLE. MANUFACTURER: CHENGDU XINJIN SHIFENG LOT 210308, DISTRIBUTOR: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2015122 SHIFENG SAFETY NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI CHENGDU SHIFENG MEDICAL TECHNOLOGY CO.,LTD 210308

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown