BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUROS GREEN CAP

    MDR report key: 23533716 · Received November 12, 2025

    Report

    Report Number
    MW5178767
    Event Type
    Injury
    Date Received
    November 12, 2025
    Date of Event
    October 11, 2025
    Report Date
    November 5, 2025
    Manufacturer
    3M COMPANY
    Product Code
    QBP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    GREEN ALCOHOL CAP NOTED ON CHEST TUBE AT THE PLEURAL SPECIMEN PORT (NEAR ATRIUM NOT STOPCOCK) FOR PATIENT IN ROOM (B)(6) BY DAYSHIFT RN. PATIENT HAD CONTINUOUSLY INCREASED SUBCUTANEOUS AIR TO CHEST AND NECK. GREEN CAP REMOVED AND PATIENT STATED TO RN, ~WHATEVER DID YOU DO THAT JUST MADE IT SO MUCH EASIER TO BREATH? ~. DR INFORMED RN THERE SHOULD NEVER BE A GREEN CAP ON THAT SITE AS IT OPENS TO CIRCUIT AND CAN ACTUALLY LET AIR IN. PATIENT ACQUIRED SO MUCH SC; HE REQUIRED BILATERAL GILLS WITH WOUND VACS. GETINGE OASIS CHEST TUBE AND CUROS GREEN CAP. CHEST TUBE MANUFACTURER DOES NOT ADVISE ONE WAY OR THE OTHER TO USE THESE CAPS, AS THEY HAVE NEVER HAD THIS REPORTED TO THEM. REP FROM 3M/SOLVENTA DID NOT RETURN CALLS X3 WITH VOICEMAILS AFTER ESTABLISHING INITIAL EMAIL CONTACT. INSTRUCTIONS FOR CHEST TUBE DO NOT MENTION USING CAPS, BUT INSTEAD SWABBING THE SAMPLING PORT WITH ALCOHOL PRIOR TO AND AFTER COLLECTION OF SAMPLES. AFTER REMOVING CAP, DEVICE FUNCTIONED AS IT SHOULD. WE BELIEVE THAT THE CAP MAY HAVE BEEN PLACED AT AN ANGLE, AS PREVIOUS MAUDE SEARCHES HAVE SHOWN THAT THIS WAS REPORTED IN 2017 ON IV TUBING THAT RESULTED IN LEAKAGES OF FLUID OUT OF THE PORT. PT CODE: 1816. DEVICE CODES: 2946, 1670. REF REPORT: MW5178696.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1932338 CUROS GREEN CAP CAP, DEVICE DISINFECTANT QBP 3M COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Hospitalization| R GETINGE OASIS 3600 CHEST TUBE-(B)(6) 2025.