BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPOINT

    MDR report key: 17134036 · Received June 15, 2023

    Report

    Report Number
    17134036
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Date of Event
    June 5, 2023
    Report Date
    June 6, 2023
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Product Code
    FMI
    UDI-DI
    00613703852908
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT PRESENTED TO THE INFUSION CENTER FOR VIDAZA INJECTIONS. PATIENT REPORTS SIGNIFICANT PAIN/DISCOMFORT WITH OUR CURRENT NEEDLE SYSTEM. EASYPOINT NEEDLE: 25G X 5/8". RETRACTABLE TECHNOLOGIES INC LOT: K211201. PATIENT REQUESTS THAT NURSING REMOVE THE NEEDLE AND THEN DISENGAGE TO DECREASE THE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1874658 EASYPOINT NEEDLE, HYPODERMIC, SINGLE LUMEN FMI RETRACTABLE TECHNOLOGIES, INC. 85291 K211201 00613703852908

    Patients

    Seq Age Sex Outcome Treatment
    1 25915 DA Female Other