BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LHK CHRISTUS WESTOVER HILLS

    MDR report key: 19095337 · Received April 12, 2024

    Report

    Report Number
    3004122598-2024-00033
    Event Type
    Malfunction
    Date Received
    April 12, 2024
    Date of Event
    January 22, 2024
    Report Date
    April 12, 2024
    Manufacturer
    PRODUCTOS MEDLINE S.A. DE C.V.
    Product Code
    OES
    UDI-DI
    40195327460090
    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 BACKING OFF THE MANIFOLD DURING PROCEDURES". THERE WAS NO FURTHER INFORMATION. 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 BACKING OFF THE MANIFOLD DURING PROCEDURES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779643 LHK CHRISTUS WESTOVER HILLS OES PRODUCTOS MEDLINE S.A. DE C.V. 23HBQ824 40195327460090

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown