BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYTORICH RED WHITE CAPS

    MDR report key: 20892517 · Received December 10, 2024

    Report

    Report Number
    20892517
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    November 6, 2024
    Report Date
    November 21, 2024
    Manufacturer
    THERMO FISHER SCIENTIFIC, INC
    Product Code
    LEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    "DOING ION BRONCHOSCOPIES IN SPOR 17 IN WHICH THE CYTORICH RED WHITE CAPS WERE BREAKING. WE HAD 2 BREAKS AFTER A CASE IN WHICH WE HAD TO MAKE SURE THE SPECIMEN WAS STILL IN THE CUP, AND 3 IN THIS CURRENT CASE. 144469 NEW LOT 140695 DOES NOT HAVE THE DEFECT/CRACK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634081 CYTORICH RED WHITE CAPS PRESERVATIVE, CYTOLOGICAL LEA THERMO FISHER SCIENTIFIC, INC B9990802 144469

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose