BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYPOINT NEEDLE

    MDR report key: 16350946 · Received February 9, 2023

    Report

    Report Number
    MW5114836
    Event Type
    Injury
    Date Received
    February 9, 2023
    Date of Event
    December 1, 2022
    Report Date
    February 7, 2023
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TWO INCIDENTS ON THIS TYPE OF NEEDLE. FIRST WAS (B)(6) 2022 AND SECOND WAS (B)(6) 2023 DIFFERENT PHARMACISTS, DIFFERENT STORES. PHARMACIST WAS GIVING A VACCINE TO A PATIENT USING AN EASYPOINT SYRINGE W NEEDLE, 25 G 1 " AND THIS NEEDLE INSTEAD OF RETRACTING WITHIN ITSELF THE NEEDLE DETACHED AND WAS STICKING OUT OF THE PATIENT'S ARM. PATIENT WAS UNHARMED BUT THE PHARMACIST HAD TO PULL IT OUT WITH THEIR GLOVED FINGERS WITHOUT THE PATIENT AWARE. THE VACCINE HAD INJECTED. ONE LOT NUMBER K211009 AND SECOND LOT NUMBER K211008. BOTH DEVICES MADE IN CHINA FOR RETRACTABLE TECHNOLOGIES OUT OF (B)(4). SCENARIO'S BOTH THE SAME. ONCE THE SAFETY ENGAGES INSTEAD OF THE NEEDLE RETRACTING INTO THE SYRINGE IT IS LEFT STICKING OUT OF THE PATIENT'S ARM. PLEASE CONTACT ME IF YOU HAVE FURTHER QUESTIONS. REFERENCE REPORT #MW5114837.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47366 EASYPOINT NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI RETRACTABLE TECHNOLOGIES, INC. K211009

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention