BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LHK AUGUSTA HEALTH CARE

    MDR report key: 19125764 · Received April 17, 2024

    Report

    Report Number
    1417592-2024-00518
    Event Type
    Malfunction
    Date Received
    April 17, 2024
    Date of Event
    January 23, 2024
    Report Date
    March 5, 2026
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    OES
    UDI-DI
    40195327473182
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE TO D9: IS THIS DEVICE AVAILABLE FOR EVALUATION? UPDATE TO H3: DEVICE EVALUATED BY MANUFACTURER? UPDATE TO H6: TYPE OF INVESTIGATION (B). UPDATE TO H6: INVESTIGATION FINDINGS (C).

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, "IT REALLY DOES SEEM TO BE A MIXTURE OF PRE-PROCEDURE AND MIDDLE OF THE PROCEDURE OCCURRENCES OF THE SAME ISSUE HAPPENING WHERE THE SYRINGE WILL NOT STAY ON THE MANIFOLD WITHOUT PHYSICALLY BEING HELD IN PLACE". THERE IS NO FURTHER INFORMATION. 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 CUSTOMER, "IT REALLY DOES SEEM TO BE A MIXTURE OF PRE-PROCEDURE AND MIDDLE OF THE PROCEDURE OCCURRENCES OF THE SAME ISSUE HAPPENING WHERE THE SYRINGE WILL NOT STAY ON THE MANIFOLD WITHOUT PHYSICALLY BEING HELD IN PLACE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154699 LHK AUGUSTA HEALTH CARE OES MEDLINE INDUSTRIES, LP 23JBV645 40195327473182

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown