BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 21761478 · Received April 3, 2025

    Report

    Report Number
    21761478
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    January 28, 2025
    Report Date
    April 1, 2025
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    OHD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    "NOTED A HOLE ON A MAYO STAND COVER FROM THE DAVINCI PROCEDURE PACK. NOTED MAYO STAND COVER STUCK TO ITSELF. WHOLE FIRST SET UP WAS CONTAMINATED. PULLED ANOTHER PACK TO OPEN, MAYO STAND COVER ALSO STUCK HARD TO THE PAPER PART OF THE COVER, HAS A HOLE WHEN PULLED APART. PULLED NEW MAYO STAND COVERS FROM THE CORE. CHARGE NURSE INFORMED. REP [REDACTED] NOTIFIED". MANUFACTURER RESPONSE FOR DAVINCI PROCEDURE PACK, DAVINCI PROCEDURE PACK (PER SITE REPORTER). PER CLINICAL MATERIALS, "I WILL NOT RETURN THE PRODUCT TO MFG. PER SALES REP, THEY WILL INVESTIGATE THE AFFECTED LOT NUMBER." REP IS [REDACTED] FROM CARDINAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1444389 CARDINAL HEALTH GYNECOLOGICAL LAPAROSCOPIC KIT OHD CARDINAL HEALTH 200, LLC SBAOCDPSRI 407228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown