BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE, LUER LOCK, STERILE, 3ML

    MDR report key: 19001454 · Received March 28, 2024

    Report

    Report Number
    1417592-2024-00239
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Date of Event
    May 30, 2019
    Report Date
    March 28, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    FMF
    UDI-DI
    30080196310160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT "FLUID IS PUSHING BACKWARD THRU THE STOPPER" OF THE SYRINGE PLUNGER. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE. FOUR (4) BOXES OF PRODUCT IN USED CONDITION WAS RETURNED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WAS UNABLE TO REPRODUCE OR CONFIRM THE REPORTED PROBLEM/ISSUE. IN AN ABUNDANCE OF CAUTION, AND IN RESPONSE TO AN FDA 483 ISSUED FOR CFN 1417592 ON 22-JAN-2024, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED. ADDITIONAL PRODUCT LOT REPORTED = 180820, 180920

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "FLUID IS PUSHING BACKWARD THRU THE STOPPER" OF THE SYRINGE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2389504 SYRINGE, LUER LOCK, STERILE, 3ML FMF MEDLINE INDUSTRIES, LP SYR103010Z 180620 30080196310160

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other