BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 23003783 · Received September 9, 2025

    Report

    Report Number
    23003783
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 19, 2025
    Report Date
    August 26, 2025
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    OGR
    UDI-DI
    10198459135385
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    UPON OPENING SURGICAL PACK "[REDACTED] HEAD & NECK PACK", THE CST [CERTIFIED SURGICAL TECHNOLOGIST] NOTICED A BROWN FOREIGN OBJECT IN THE STACK OF RAYTECS "4X4 XRAY GAUZE". CST IDENTIFIED OBJECT AS POTENTIALLY UNSTERILE, AND PACK CONTAMINATED. CST REMOVED THE PACK FROM OR AS WELL AS ALL OPENED ITEMS, THEN USED A NEW PACK AND SUPPLIES. PATIENT WAS NOT IN THE ROOM AT TIME OF OPENING CONTAMINATED PACK. AFTER NEW PACK AND ITEMS WERE OPENED, CASE COMPLETED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2406862 MEDLINE INDUSTRIES, INC. EAR, NOSE, AND THROAT SURGICAL TRAY OGR MEDLINE INDUSTRIES, INC. DYNJ33656F (10)25DME170 10198459135385

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown