BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Q2 24HR DUOCARE VAP KIT- THUMB PORT

    MDR report key: 22095642 · Received May 28, 2025

    Report

    Report Number
    1417592-2025-00258
    Event Type
    Injury
    Date Received
    May 28, 2025
    Date of Event
    April 30, 2025
    Report Date
    May 28, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    NXZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, WHILE DOING ORAL CARE THE PATIENT "BIT DOWN ON THE PRODUCT" AND WHEN THE PRODUCT WAS REMOVED FROM THE PATIENT'S MOUTH, "THE SPONGE WAS NOT CONNECTED ON THE END". THE CUSTOMER REPORTED AFTER THE INCIDENT OCCURRED, THEY WERE NOT ABLE TO LOCATE THE SPONGE AND A "BRONCHOSCOPY" WAS PERFORMED TO ATTEMPT TO LOCATE THE SPONGE. THE CUSTOMER REPORTED THE LOCATION OF THE SPONGE WAS NEVER IDENTIFIED, BUT THE PATIENT DID HAVE "DIARRHEA AND ABDOMINAL CRAMPS". THE CUSTOMER REPORTED A "GENERAL SURGEON" WAS CONSULTED BY NO ADDITIONAL PROCEDURES WERE REQUIRED. THE CUSTOMER DID NOT REPORT ANY SERIOUS INJURY RELATED TO THE REPORTED INCIDENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. 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

    ACCORDING TO THE CUSTOMER, WHILE DOING ORAL CARE THE PATIENT "BIT DOWN ON THE PRODUCT" AND WHEN THE PRODUCT WAS REMOVED FROM THE PATIENT'S MOUTH, "THE SPONGE WAS NOT CONNECTED ON THE END".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330908 Q2 24HR DUOCARE VAP KIT- THUMB PORT NXZ MEDLINE INDUSTRIES, LP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other