BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 12982979 · Received December 13, 2021

    Report

    Report Number
    12982979
    Event Type
    Malfunction
    Date Received
    December 13, 2021
    Date of Event
    November 22, 2021
    Report Date
    November 23, 2021
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    OHD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING SET UP FOR A PROCEDURE, THE SURGICAL TECH FOUND A BLACK PIECE OF DEBRIS IN ONE OF THE RAYTECS FROM THE CARDINAL CUSTOM PACK - GYN LAPAROSCOPY PACK. THE ENTIRE TABLE WAS REPLACED WITH NEW SUPPLIES. IT DID NOT REACH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1887587 CARDINAL HEALTH GYNECOLOGICAL LAPAROSCOPIC KIT OHD CARDINAL HEALTH 200, LLC SMA12LPKGS 630103

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown