BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREPOINT SAFETY 1ML/23G X 1 LEURLOCK SYRINGE AND SAFETY NEEDLE

    MDR report key: 11552881 · Received March 22, 2021

    Report

    Report Number
    MW5100171
    Event Type
    Malfunction
    Date Received
    March 22, 2021
    Date of Event
    March 18, 2021
    Report Date
    March 18, 2021
    Manufacturer
    ALLISON MEDICAL, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MODERNA TREATMENT UNDER EMERGENCY USE AUTHORIZATION(EUA): CAREPOINT SAFETY NEEDLES ARE BREAKING AT THE END OF THE SYRINGE WHEN LPN ENGAGING THE SAFETY DEVICE AND RESULTED IN A NEEDLE STICK. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444837 CAREPOINT SAFETY 1ML/23G X 1 LEURLOCK SYRINGE AND SAFETY NEEDLE SYRINGE, PISTON FMF ALLISON MEDICAL, INC. 20200915

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other