BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 25179522 · Received May 14, 2026

    Report

    Report Number
    1417592-2026-01292
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    April 14, 2026
    Report Date
    May 14, 2026
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    NXZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT, WHEN PERFORMING ORAL CARE USING A MEDLINE GREEN SUCTION SPONGE ON THIS INTUBATED PATIENT. THE GREEN SPONGE FELL OFF IN THE PATIENT'S MOUTH, AT BACK OF THROAT AND HAD TO BE MANUALLY REMOVED FROM THROAT WITHOUT DIFFICULTY. THIS WAS PART OF THE MEDLINE DUOCARE, CLINICAL ORAL RINSE Q2 24 HOUR PACKAGE. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, WHEN PERFORMING ORAL CARE USING A MEDLINE GREEN SUCTION SPONGE ON THIS INTUBATED PATIENT. THE GREEN SPONGE FELL OFF IN THE PATIENT'S MOUTH, AT BACK OF THROAT AND HAD TO BE MANUALLY REMOVED FROM THROAT WITHOUT DIFFICULTY. THIS WAS PART OF THE MEDLINE DUOCARE, CLINICAL ORAL RINSE Q2 24 HOUR PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334144 MEDLINE Q2 24HR DUO/CHG VAP KIT-THUMB PORT NXZ MEDLINE INDUSTRIES, LP 26-019-1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown