BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE-MICROTEK

    MDR report key: 23218763 · Received October 5, 2025

    Report

    Report Number
    3012811961-2025-00010
    Event Type
    Malfunction
    Date Received
    October 5, 2025
    Date of Event
    September 8, 2025
    Report Date
    October 5, 2025
    Manufacturer
    MICROTEK MEDICAL LLC
    Product Code
    PUI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING RECENT PROCEDURES, A FEW HOLES WERE OBSERVED IN FLUID WARMER DRAPES. THE ISSUE WAS DISCOVERED AT THE END OF THE PROCEDURE, AND THE PACKAGING COULD NOT BE RETRIEVED, SO LOT NUMBERS WERE NOT AVAILABLE. THE CUSTOMER INDICATED THIS IS A PATIENT SAFETY CONCERN AND PLANS TO INSTRUCT STAFF TO RETAIN PACKAGING FOR FUTURE EVALUATION. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1650854 MEDLINE-MICROTEK WARMER DRAPE, FOR USE WITH ORS-2000 SERIES FLUID WARMING SYSTEM, 112 CM X 112 CM PUI MICROTEK MEDICAL LLC ORS-100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown