BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 11612760 · Received April 5, 2021

    Report

    Report Number
    11612760
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Date of Event
    March 22, 2021
    Report Date
    March 31, 2021
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    OHD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SURGICAL TECH WAS SETTING UP FOR THE PROCEDURE AND NOTICED A FOREIGN OBJECT IN THE BASIN OF A GYN LAPAROSCOPY PACK. THE FOREIGN OBJECT APPEARED TO BE A SMALL BUG. THE PACK WAS WASTED AND SUPPLIES WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509608 CARDINAL HEALTH GYNECOLOGICAL LAPAROSCOPIC KIT OHD CARDINAL HEALTH 200, LLC SMA12LPKGR 526167

    Patients

    Seq Age Sex Outcome Treatment
    1