BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVIROTEST

    MDR report key: 11602746 · Received March 31, 2021

    Report

    Report Number
    MW5100482
    Event Type
    Malfunction
    Date Received
    March 31, 2021
    Date of Event
    March 30, 2021
    Report Date
    March 30, 2021
    Manufacturer
    Q.I. MEDICAL, INC.
    Product Code
    JSG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    OUR HOME INFUSION COMPANY USES QI MEDICAL'S ENVIROTEST AS PART OF OUR ENVIRONMENTAL MONITORING PROGRAM IN OUR CLEAN ROOM. ONE OF OUR TECHNICIANS TOOK A CONTAINER OUT OF THE BOX TO USE TODAY AND NOTICED THERE WAS GROWTH ON BOTH SIDES OF THE PADDLE. THE PLASTIC CONTAINER WITH THE RED TOP THAT THE PADDLE IS IN WAS, AND STILL IS, COMPLETELY SEALED. THE QI MEDICAL ITEM NUMBER IS ET1000, THE LOT NUMBER IS 1897520, AND THE EXPIRATION DATE IS 8/28/21. THIS CONTAINER/PADDLE IS THE ONLY ONE IN THE BOX THAT HAS VISIBLE GROWTH. WE HAVE ALREADY USED PADDLES WITH THIS LOT NUMBER IN OUR PAST MONTHLY ENVIRONMENTAL MONITORING. EVERY MONTH FROM 11/25/2020 UNTIL NOW, WE HAVE USED ENVIROTEST PADDLES WITH THE LOT NUMBER 1897520. NO GROWTH WAS OBSERVED ON THOSE PADDLES. WE STILL HAVE 20 CONTAINERS/PADDLES WITH THE LOT NUMBER 1897520 LEFT IN STOCK. I CALLED QI MEDICAL THIS MORNING TO REPORT THIS. I LEFT A MESSAGE FOR SOMEONE TO CALL ME BACK. I CURRENTLY HAVE THE AFFECTED PRODUCT IN OUR PHARMACY. I WILL BE SENDING IT TO QI MEDICAL IF THEY REQUEST IT WHEN THEY FOLLOW UP. IF THEY DO NOT, I WILL HAVE IT TESTED AT OUR LOCAL LAB. I ALSO HAVE PICTURES AVAILABLE OF THE AFFECTED PRODUCT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497542 ENVIROTEST CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG Q.I. MEDICAL, INC. ET1000 1897520

    Patients

    Seq Age Sex Outcome Treatment
    1