BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LHK, US, ADVENTHEALTH ORLANDO

    MDR report key: 22375767 · Received July 1, 2025

    Report

    Report Number
    3015910259-2025-00047
    Event Type
    Malfunction
    Date Received
    July 1, 2025
    Date of Event
    June 4, 2025
    Report Date
    July 1, 2025
    Manufacturer
    MEDLINE-NAMIC
    Product Code
    OES
    UDI-DI
    10195327598808
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY THE CONTROL SYRINGE IS NOT THREADING, OR THREADING ON, BUT NOT STAYING TIGHT. 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. 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 FOR THE REPORTED PROBLEM/ISSUE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    ACCORDING TO THE FACILITY THE CONTROL SYRINGE IS NOT THREADING, OR THREADING ON, BUT NOT STAYING TIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1314512 LHK, US, ADVENTHEALTH ORLANDO OES MEDLINE-NAMIC 24LBQ470 10195327598808

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown