BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD STERLING SG

    MDR report key: 24321283 · Received February 12, 2026

    Report

    Report Number
    24321283
    Event Type
    Malfunction
    Date Received
    February 12, 2026
    Date of Event
    October 30, 2025
    Report Date
    December 24, 2025
    Manufacturer
    O & M HALYARD, INC.
    Product Code
    LZC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    NO PATIENT WAS INVOLVED. A NURSE IN THE OPERATING ROOM OPENED A NEW BOX OF SIZE SMALL EXAM GLOVES WHICH HAD BEEN STORED ON THE STOCK SUPPLY CART. SHE BROKE THE SEAL ON THE BOX AND PULLED OUT TWO INDIVIDUAL GLOVES FROM THE UNUSED, BRAND NEW, UNOPENED BOX. WHEN SHE DONNED ONE OF THE GLOVES, SHE FELT SOMETHING "ODD". WHEN SHE PULLED HER HAND BACK OUT OF THE NON-STERILE EXAM GLOVE, HER HAND WAS COVERED IN "WHAT APPEARED TO BE EITHER OLD OIL OR A DIRTY LUBRICANT, POSSIBLY USED FOR MACHINERY." THE NURSE STATED THAT IT TOOK QUITE SOME TIME TO SCRUB THE UNKNOWN SUBSTANCE OFF OF HER HAND ONCE THE DIRTY GLOVE WAS REMOVED. THE BOX OF GLOVES WAS TAKEN FROM THE OPERATING ROOM STOCKROOM AREA AND SHOWN TO LEADERSHIP. NO HARM TO THE EMPLOYEE AND THE ITEM WAS NOT IN THE VICINITY OF ANY STERILE FIELD, NOT DID IT OCCUR DURING ANY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381672 HALYARD STERLING SG PATIENT EXAMINATION GLOVE, SPECIALTY LZC O & M HALYARD, INC. 41658 SM167ZZZ_41AX

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female