BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREPOINT

    MDR report key: 18913478 · Received March 15, 2024

    Report

    Report Number
    1000138447-2024-00002
    Event Type
    Malfunction
    Date Received
    March 15, 2024
    Date of Event
    February 22, 2024
    Report Date
    February 23, 2024
    Manufacturer
    JUNG RIM MEDICAL INDUSTRIAL CO., LTD.
    Product Code
    FMF
    UDI-DI
    00786227040554
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    POLY HUB IS NOT STAYING ATTACHED TO THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875401 CAREPOINT 5ML LUER LOCK SYRINGE FMF JUNG RIM MEDICAL INDUSTRIAL CO., LTD. 220405 00786227040554

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown