BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 11768807 · Received May 4, 2021

    Report

    Report Number
    11768807
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 15, 2021
    Report Date
    April 28, 2021
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    FDE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A HAIR WAS FOUND IN A CARDINAL HEALTH LAP CHOLECYSTECTOMY PACK DURING THE PRE-OPERATIVE SETUP FOR A CASE. THE ENTIRE FIELD HAD TO BE REDONE DUE TO CONTAMINATION, CAUSING DELAY OF CASE AND WASTE OF 3 TRAYS AND DISPOSABLE SUPPLIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668885 CARDINAL HEALTH LAPAROSCOPY KIT FDE CARDINAL HEALTH 200, LLC SBA12LC76F 583235

    Patients

    Seq Age Sex Outcome Treatment
    1