BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREPOINT

    MDR report key: 17121470 · Received June 13, 2023

    Report

    Report Number
    1000138447-2023-00006
    Event Type
    Malfunction
    Date Received
    June 13, 2023
    Date of Event
    April 17, 2021
    Report Date
    June 13, 2023
    Manufacturer
    JIANGSU MICSAFE MEDICAL TECHNOLOGY CO., LTD
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    CAREPOINT SAFETY FIRST LUER LOCK 1ML 23 GAUGE/1 INCH SYRINGE, REF (B)(4) TREATMENT UNDER EMERGENCY USE AUTHORIZATION (EUA). SYRINGE WAS BEING USED TO DELIVER JANSSEN COVID 19 VACCINE AND WAS PROVIDED IN OUR ANCILLARY KITS FOR USE, 2 TIMES THE NEEDLE FELL OFF THE SYRINGE DURING VACCINE ADMINISTRATION DESPITE TIGHTENING THE LUER LOCK CONNECTION PRIOR TO USE, 1 TIME THE SYRINGE STOPPER WAS SLANTED AND WOULDN'T ALLOW A FULL DOSE TO BE ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206216 CAREPOINT 1ML SYRINGE WITH 23G X 1" POLYHUB NEEDLE FMF JIANGSU MICSAFE MEDICAL TECHNOLOGY CO., LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other