BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREPOINT

    MDR report key: 15959940 · Received December 12, 2022

    Report

    Report Number
    1000138447-2022-00009
    Event Type
    Malfunction
    Date Received
    December 12, 2022
    Date of Event
    March 18, 2021
    Report Date
    December 5, 2022
    Manufacturer
    JIANGSU MICSAFE MEDICAL TECHNOLOGY CO., LTD
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BREAK (1069) AND NEEDLE STICK/PUNCTURE (2462). 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
    425078 CAREPOINT SAFETY SYRINGE NEEDLE FMF JIANGSU MICSAFE MEDICAL TECHNOLOGY CO., LTD 35-8202 20200915

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other