BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD

    MDR report key: 21034611 · Received December 30, 2024

    Report

    Report Number
    21034611
    Event Type
    Malfunction
    Date Received
    December 30, 2024
    Date of Event
    December 17, 2024
    Report Date
    December 17, 2024
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ORTHO BAR DRAPE WAS OPENED TO FIELD, CIRCULATOR NOTICED A SLIT IN THE OUTSIDE PACKAGE AND A SLIT ON THE BLUE WRAPPER AROUND DRAPE. CIRCULATOR NOTIFIED SURGEON. SURGEON CHANGED HER GLOVES AND PUT A NEW ORTHO BAR DRAPE OVER THE CONTAMINATED ONE. ITEMS WERE DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2429581 HALYARD DRAPE, SURGICAL KKX O&M HALYARD, INC. 89381 AC2428403F

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female