BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPOINT

    MDR report key: 17134121 · Received June 15, 2023

    Report

    Report Number
    17134121
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Date of Event
    May 24, 2023
    Report Date
    May 25, 2023
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Product Code
    FMI
    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 VELCADE TREATMENT. PATIENT REPORTS MORE PAIN AND DISCOMFORT WITH THE NEW NEEDLE SYSTEM IN PLACE. EASYPOINT NEEDLE, RETRACTABLE TECHNOLOGIES INC, LOT: K211201.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1874697 EASYPOINT NEEDLE, HYPODERMIC, SINGLE LUMEN FMI RETRACTABLE TECHNOLOGIES, INC. 85291 K211201

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown