BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METHODIST. SAN ANTONIO,LHK

    MDR report key: 23533287 · Received November 12, 2025

    Report

    Report Number
    3015910259-2025-00104
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    October 15, 2025
    Report Date
    November 17, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP - NAMIC
    Product Code
    OEZ
    UDI-DI
    10195327076450
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE TO H6: INVESTIGATION FINDINGS (C). UPDATE TO H6: INVESTIGATION CONCLUSIONS (D).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT ON MULTIPLE OCCASIONS, INCLUDING (B)(6) 2025, THE "CONTROL SYRINGE UNRAVELS FROM THE MANIFOLD." THE CUSTOMER STATED THAT THE PROCEDURE WAS ABLE TO BE COMPLETED "WITH A SUBSTITUTE SYRINGE." 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

    IT WAS REPORTED THAT ON MULTIPLE OCCASIONS, INCLUDING (B)(6) 2025, THE "CONTROL SYRINGE UNRAVELS FROM THE MANIFOLD." THE CUSTOMER STATED THAT THE PROCEDURE WAS ABLE TO BE COMPLETED "WITH A SUBSTITUTE SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1980586 METHODIST. SAN ANTONIO,LHK OEZ MEDLINE INDUSTRIES, LP - NAMIC 25FBH292 10195327076450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other