BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN

    MDR report key: 10550666 · Received September 17, 2020

    Report

    Report Number
    3014527682-2020-00014
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Date of Event
    September 8, 2020
    Report Date
    September 17, 2020
    Manufacturer
    COVIDIEN/CARDINAL HEALTH
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THERE WAS FRAYED RAYTEC FOUND IN PACK. NO HARM TO THE PATIENT NO DELAY TO CASE. DEFECTIVE PRODUCT WAS REMOVED FROM THE STERILE FIELD, AND STERILE PRODUCT WAS OPENED FROM SUPPLY. THE FRAYED RAYTEC WAS CONTAINED WITHIN ROI CPS, LLC CUSTOM KIT 88013702 (LAP CHOLE-OKC) LOT NUMBER 80689U.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016298 COVIDIEN SPONGE GAUZE 4X4 16 PLY X-RAY GDY COVIDIEN/CARDINAL HEALTH 7148 20A064262

    Patients

    Seq Age Sex Outcome Treatment
    1