BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE-MICROTEK

    MDR report key: 23538724 · Received November 12, 2025

    Report

    Report Number
    3012811961-2025-00012
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    September 9, 2025
    Report Date
    November 12, 2025
    Manufacturer
    MICROTEK MEDICAL LLC
    Product Code
    PUI
    UDI-DI
    00748426140466
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDLINE RECEIVED A COMPLAINT FROM (B)(6) HOSPITAL ON (B)(6) 2025, REGARDING TWO NON-STERILE SLUSH WARMER PLATE DRAPES (PART NUMBER: ORS-330N) THAT LEAKED DURING USE DUE TO HOLES IN THE MATERIAL. THE DEFECT WAS CONFIRMED BASED ON CUSTOMER-PROVIDED IMAGES; HOWEVER, NO PHYSICAL SAMPLES WERE RETURNED. A THOROUGH INVESTIGATION WAS CONDUCTED, INCLUDING EVALUATION OF MANUFACTURING PROCESSES, EQUIPMENT, MATERIALS, PERSONNEL, AND ENVIRONMENTAL CONDITIONS. NO ISSUES OR CHANGES WERE IDENTIFIED THAT COULD CONTRIBUTE TO THE REPORTED DEFECT. ALL RELEVANT PROCEDURES AND QUALITY CONTROLS WERE FOUND TO BE PROPERLY IMPLEMENTED AND EFFECTIVE, INCLUDING VISUAL INSPECTIONS AND FIRST ARTICLE EVALUATIONS.NO SIMILAR COMPLAINTS WERE REPORTED FOR THIS PRODUCT IN THE PAST YEAR. THE DEFECT COULD NOT BE REPLICATED, AND THE ROOT CAUSE REMAINS UNDETERMINED. THE RISK ASSESSMENT CONCLUDED A LOW RISK LEVEL, AND NO CORRECTIVE OR FIELD ACTIONS WERE DEEMED NECESSARY. A QUALITY ALERT WAS ISSUED, AND ONGOING MONITORING OF COMPLAINT TRENDS WILL CONTINUE.

    Description of Event or Problem · 0

    THE FACILITY REPORTED THAT A SLUSH DRAPE FROM A VALVE PACK LEAKED DURING A SURGICAL PROCEDURE. A HOLE WAS DISCOVERED AT THE END OF THE CASE WHEN THE DRAPE WAS REMOVED FROM THE WARMER, REVEALING SALINE AND SURGICAL CONTENTS POOLED AT THE BOTTOM OF THE MACHINE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. NO INJURY OR MEDICAL INTERVENTION WAS REQUIRED; HOWEVER, ADDITIONAL ANTIBIOTICS WERE ADMINISTERED AS A PRECAUTION PER THE SURGEON AND ANESTHESIA TEAM'S RECOMMENDATION. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1984048 MEDLINE-MICROTEK SLUSH + WARMER PLATE-DRAPE¿, FOR USE WITH ORS-1058 HUSH-SLUSH¿ PUI MICROTEK MEDICAL LLC ORS-330N 254LA1200, 314LA0400 00748426140466

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male