BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LHK, US, REID HOSPITAL

    MDR report key: 23536439 · Received November 12, 2025

    Report

    Report Number
    3015910259-2025-00105
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    October 13, 2025
    Report Date
    November 12, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP-NAMIC
    Product Code
    OES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY, THERE IS AIR GETTING IN THE CONTRAST LINE AND THE CONTROL SYRINGE AND PRESSURE LINE BACK OFF THE PORTS OF THE MANIFOLD. NO ADDITIONAL INFORMATION AT THIS TIME. THE PRODUCT HAS BEEN REQUESTED FOR EVALUATION. 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 (B)(4) 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, THERE IS AIR GETTING IN THE CONTRAST LINE AND THE CONTROL SYRINGE AND PRESSURE LINE BACK OFF THE PORTS OF THE MANIFOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2593026 LHK, US, REID HOSPITAL OES MEDLINE INDUSTRIES, LP-NAMIC 25GBC906

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown