BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGARD

    MDR report key: 14477747 · Received May 23, 2022

    Report

    Report Number
    3014527682-2022-00006
    Event Type
    Malfunction
    Date Received
    May 23, 2022
    Date of Event
    May 18, 2022
    Report Date
    May 23, 2022
    Manufacturer
    ROI CPS, LLC
    Product Code
    OEZ
    UDI-DI
    10194717101949
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ROI CPS, LLC BECAME AWARE, AFTER RECEIVING AN INQUIRY FROM AN END USER FACILITY REGARDING A NON-STERILE ULTRASOUND GEL 20GM NS BEING USED IN A STERILE CV MINOR PROCEDURE KIT. THE NON-STERILE ITEM IS IN A FOIL PACKAGE THAT IS LABELED AS NON-STERILE AND CANNOT BE STERILIZED IN THE ROI CPS, LLC STERILIZATION CYCLE DUE TO PENETRATION OF EO GAS BEING PREVENTED BY THE FOIL PACKAGING. THE GEL IS REQUIRED TO BE STERILE FOR USE IN THE CV MINOR PROCEDURE KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704172 REGARD CV MINOR KIT OEZ ROI CPS, LLC CV00979A 91423 10194717101949

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown