BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE-MICROTEK

    MDR report key: 23218762 · Received October 5, 2025

    Report

    Report Number
    3012811961-2025-00009
    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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT WATER WAS FOUND IN THE BOTTOM OF A SALINE FLUID WARMER, INDICATING THE PRODUCT HAD A HOLE. IT IS UNCLEAR WHEN THE HOLE DEVELOPED. THE PHYSICIAN WAS IMMEDIATELY INFORMED AND ADVISED THE TEAM THAT THE PATIENT WOULD RECEIVE ADDITIONAL ANTIBIOTICS POSTOPERATIVELY IN THE ICU. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1650853 MEDLINE-MICROTEK WARMER DRAPE, FOR USE WITH ORS-2000 SERIES FLUID WARMING SYSTEM PUI MICROTEK MEDICAL LLC ORS-300 3135LA1400

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown