BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE-MICROTEK

    MDR report key: 23680721 · Received December 1, 2025

    Report

    Report Number
    3012811961-2025-00014
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Report Date
    December 1, 2025
    Manufacturer
    MICROTEK MEDICAL LLC
    Product Code
    PUI
    UDI-DI
    00748426140329
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER INVESTIGATED A REPORTED DEFECT INVOLVING HOLES IN THE PRODUCT. DEVICE HISTORY RECORDS FOR THE AFFECTED LOT WERE REVIEWED, AND NO NONCONFORMANCE WAS IDENTIFIED DURING MANUFACTURING. ALL ESTABLISHED PROCEDURES AND QUALITY CONTROLS WERE CONFIRMED AS ADEQUATE, AND THE DEFECT COULD NOT BE REPLICATED UNDER CONTROLLED CONDITIONS. DUE TO THE ABSENCE OF SAMPLES OR SUPPORTING EVIDENCE, THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. RISK ASSESSMENT CLASSIFIED THE ISSUE AS LOW. IMMEDIATE ACTIONS INCLUDED ISSUING A QUALITY ALERT AND INITIATING TREND MONITORING FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OR STAFF NOTICED THE SLUSH DRAPE ESD340 HAD A HOLE. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2150283 MEDLINE-MICROTEK HUSH-SLUSH¿ 2.0 SLUSH + WARMER DISC-DRAPE, FOR USE WITH THE HUSH-SLUSH¿ 2.0 PUI MICROTEK MEDICAL LLC ESD340 5374LA1600 00748426140329

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown