BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREPOINT SAFETY / LEUER LOCK SYRINGE

    MDR report key: 11699938 · Received April 20, 2021

    Report

    Report Number
    MW5100866
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    April 11, 2021
    Report Date
    April 19, 2021
    Manufacturer
    ALLISON MEDICAL, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SYRINGE USE FOR COVID-19 UNDER EMERGENCY USE AUTHORIZATION (EUA): CAREPOINT SAFETY SYRINGES HAD 2 DIFFERENT ISSUES THE SYRINGE AND NEEDLE WERE TIGHTENED AT THE BEVEL YET THEY CONTINUE TO DETACH FROM EACH OTHER. WHEN A NEW/DIFFERENT BRAND NEEDLE ADDED - WORKS WELL. TWO (2) 3ML SYRINGE/NEEDLE LOT 20201005 - STOPPER IN SYRINGE (TALL) MOVED HORIZONTAL, CAUSING A BARRIER TO NOT ALLOW VACCINE TO EXPEL FROM SYRINGE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588950 CAREPOINT SAFETY / LEUER LOCK SYRINGE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI ALLISON MEDICAL, INC. 20201005

    Patients

    Seq Age Sex Outcome Treatment
    1