BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SSCOR, INC.

    MDR report key: 24403205 · Received February 20, 2026

    Report

    Report Number
    2022724-2026-00002
    Event Type
    Malfunction
    Date Received
    February 20, 2026
    Date of Event
    November 8, 2025
    Report Date
    February 20, 2026
    Manufacturer
    SSCOR, INC
    Product Code
    BTA
    PMA / PMN Number
    K945929
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE INTENDED USE WAS SENT TO CUSTOMER AND WAS ADVISED THAT THE DEVICE WAS USED OFF LABEL USED AS DEVICE WAS NOT MEAN TO BE USED WITH CHEST TUBES. DUE TO THE AGE OF THE DEVICE (17 YEARS) CUSTOMER WAS ADVISED THAT IT WAS BEST TO PURCHASE A NEW DEVICE RATHER THAN REPARING THE NON-CONFORMING DEVICE. REGARDLESS OF THE REPAIR PRICE, CUSTOMER APPROVED REPAIR OF DEVICE.

    Description of Event or Problem · 0

    REPORTER STATED THAT DEVICE FAILED WHILE PATIENT WAS BEING TRANSPORTED FOR AN MRI. SUCTION REQUIRED FOR CHEST TUBES WAS NOT STRONG ENOUGH WHEN USING A SUCTION Y-SITE ADAPTER TO KEEP CHEST TUBES TO SUCTION, SUCTION WAS ONLY STRONG ENOUGH FOR SINGLE SUCTION CONNECTION. IT SOUNDS LIKE THIS PATIENT HAD MULTIPLE CHEST TUBES THEY WERE TRYING TO KEEP SUCTIONED AND USED THE Y-ADAPTER CONNECTION FROM A SINGLE SUCTION LINE COMING FROM THE SUCTION PUMP ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463824 SSCOR, INC. SSCOR DUET BTA SSCOR, INC 2314

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown