BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE-MICROTEK

    MDR report key: 23547827 · Received November 13, 2025

    Report

    Report Number
    3012811961-2025-00013
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Date of Event
    August 18, 2025
    Report Date
    November 13, 2025
    Manufacturer
    MICROTEK MEDICAL LLC
    Product Code
    PUI
    UDI-DI
    00748426140329
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED A REPORT OF A SLUSH DRAPE LEAKING DURING A SURGICAL PROCEDURE. AT THE END OF THE CASE, FLUID WAS OBSERVED POOLING ON THE WARMER SIDE OF THE DRAPE. INSPECTION REVEALED A SECTION OF THE DRAPE APPEARED MELTED OR THINNED, WHICH WAS NOT NOTICED DURING SETUP. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, AND NO PATIENT INJURY OCCURRED. THE INVESTIGATION CONFIRMED THE REPORTED CONDITION BASED ON CUSTOMER INFORMATION. NO SAMPLE WAS RETURNED, AND THE DEFECT COULD NOT BE REPLICATED. DEVICE HISTORY RECORDS WERE REVIEWED, AND NO NONCONFORMANCES WERE IDENTIFIED. MANUFACTURING PROCESSES, EQUIPMENT, MATERIALS, AND ENVIRONMENTAL CONDITIONS WERE ASSESSED AND FOUND COMPLIANT. NO CHANGES OR ISSUES WERE IDENTIFIED THAT COULD CONTRIBUTE TO THE REPORTED CONDITION. THE ROOT CAUSE COULD NOT BE DETERMINED DUE TO LIMITED INFORMATION. THE EVENT APPEARS ISOLATED, AND RISK ASSESSMENT CONCLUDED A LOW RISK LEVEL.

    Description of Event or Problem · 0

    IT WAS REPROTED THAT AT THE END OF THE SURGICAL PROCEDURE, FLUID WAS OBSERVED POOLING ON THE WARMER SIDE OF THE SLUSH DRAPE. UPON INSPECTION, A SECTION OF THE DRAPE APPEARED MELTED OR THINNED, WHICH WAS NOT NOTICED DURING SETUP. THE LEAK ALLOWED SALINE AND SURGICAL CONTENTS TO COLLECT IN THE WARMER. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1923643 MEDLINE-MICROTEK HUSH-SLUSH¿ 2.0 SLUSH + WARMER DISC-DRAPE, FOR USE WITH THE HUSH-SLUSH¿ 2.0 PUI MICROTEK MEDICAL LLC ESD340 00748426140329

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown