BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M¿ CUROS¿ DISINFECTING CAP FOR NEEDLELESS CONNECTORS

    MDR report key: 23908206 · Received December 29, 2025

    Report

    Report Number
    2110898-2025-00077
    Event Type
    Injury
    Date Received
    December 29, 2025
    Date of Event
    October 11, 2025
    Report Date
    December 29, 2025
    Manufacturer
    3M COMPANY
    Product Code
    QBP
    PMA / PMN Number
    K111992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED TO SOLVENTUM FOR ANALYSIS. THE PHYSICIAN INDICATED THE CUROS CAP WAS PLACED INCORRECTLY ON THE CHEST TUBE PORT; THEREFORE, THIS EVENT IS BEING REPORTED DUE TO USE ERROR. THERE ARE NO ADVERSE TRENDS. SOLVENTUM WILL CONTINUE TO MONITOR.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED AN ADVERSE EVENT VIA A MEDWATCH REPORT INVOLVING THE USE OF A 3M¿ CUROS¿ DISINFECTING CAP FOR NEEDLELESS CONNECTORS PLACED ON A GETINGE OASIS 3600 CHEST TUBE PLEURAL SPECIMEN PORT. A DAY-SHIFT REGISTERED NURSE OBSERVED THE GREEN ALCOHOL CAP ON THE CHEST TUBE SPECIMEN PORT AFTER THE PATIENT EXHIBITED CONTINUOUSLY INCREASING SUBCUTANEOUS AIR TO THE CHEST AND NECK. THE CAP WAS REMOVED, AND THE PATIENT REPORTEDLY STATED THAT BREATHING BECAME SIGNIFICANTLY EASIER FOLLOWING REMOVAL. THE ATTENDING PHYSICIAN ADVISED THAT A GREEN ALCOHOL CAP SHOULD NOT BE PLACED ON THAT SPECIFIC CHEST TUBE PORT, AS THE PORT OPENS DIRECTLY TO THE CIRCUIT AND MAY ALLOW AIR ENTRY IF CAPPED IMPROPERLY. THE PATIENT REPORTEDLY DEVELOPED EXTENSIVE SUBCUTANEOUS EMPHYSEMA AND SUBSEQUENTLY REQUIRED BILATERAL GILL INCISIONS WITH WOUND VACUUM-ASSISTED CLOSURES. AFTER REMOVAL OF THE GREEN ALCOHOL CAP, THE CHEST TUBE REPORTEDLY FUNCTIONED AS INTENDED. THE REPORTING FACILITY BELIEVES THE ALCOHOL CAP MAY HAVE BEEN PLACED AT AN ANGLE, POTENTIALLY PREVENTING PROPER SEALING. THE CHEST TUBE WAS REPLACED DURING THE EVENING HOURS. THE GREEN ALCOHOL CAP WAS DISCOVERED LATE THE FOLLOWING MORNING. IT COULD NOT BE DETERMINED WHETHER THE CAP WAS PLACED DURING THE NIGHT SHIFT OR THE DAY SHIFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1917023 3M¿ CUROS¿ DISINFECTING CAP FOR NEEDLELESS CONNECTORS CAP, DEVICE DISINFECTANT QBP 3M COMPANY NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention