BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LHK,,CHRISTUS,,SAN MARCOS

    MDR report key: 19514766 · Received June 11, 2024

    Report

    Report Number
    3004122598-2024-00037
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Date of Event
    March 8, 2024
    Report Date
    June 11, 2024
    Manufacturer
    PRODUCTOS MEDLINE S.A. DE C.V.
    Product Code
    OES
    UDI-DI
    40195327206728
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, "THE SYRINGE WAS UNRAVELING IN THE SAMPLE. THIS HAPPENED DURING SETUP BEFORE THE PROCEDURE STARTED. BELIEVED THAT IT WAS A SYRINGE 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 CUSTOMER, "THE SYRINGE WAS UNRAVELING IN THE SAMPLE. THIS HAPPENED DURING SETUP BEFORE THE PROCEDURE STARTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204591 LHK,,CHRISTUS,,SAN MARCOS OES PRODUCTOS MEDLINE S.A. DE C.V. 23JBU608 40195327206728

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other