BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE-MICROTEK

    MDR report key: 23352411 · Received October 21, 2025

    Report

    Report Number
    3012811961-2025-00011
    Event Type
    Malfunction
    Date Received
    October 21, 2025
    Date of Event
    September 22, 2025
    Report Date
    October 21, 2025
    Manufacturer
    MICROTEK MEDICAL LLC
    Product Code
    PUI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEFECT WAS A HOLE IN THE DRAPE MATERIAL OBSERVED DURING USE, CONFIRMED THROUGH CUSTOMER IMAGE. NO SAMPLE WAS RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD AND MANUFACTURING CONTROLS SHOWED NO NON-CONFORMANCES, AND ALL PROCEDURES WERE FOLLOWED. THE ROOT CAUSE COULD NOT BE DETERMINED. RISK WAS ASSESSED AS LOW, AND A QUALITY ALERT WAS ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SETUP FOR A MINI AVR CASE, A HOLE WAS OBSERVED IN THE DRAPE COVERING THE SLUSH/WARMER MACHINE AFTER IT WAS FILLED WITH SALINE AND RUNNING. SALINE LEAKED UNDER THE COVER AND OUT OF THE BOTTOM OF THE MACHINE, CONTAMINATING THE STERILE FIELD. THE ENTIRE STERILE FIELD HAD TO BE BROKEN DOWN AND RESET, CAUSING A MINIMAL DELAY. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233791 MEDLINE-MICROTEK SLUSH + WARMER DISC-DRAPE¿ PUI MICROTEK MEDICAL LLC ORS-320 3504LA1400

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown