BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTL QCARE RX Q4 SYS W/CORINZ 20

    MDR report key: 22286979 · Received June 18, 2025

    Report

    Report Number
    0001419181-2025-00013
    Event Type
    Injury
    Date Received
    June 18, 2025
    Date of Event
    June 9, 2025
    Report Date
    June 18, 2025
    Manufacturer
    SAGE PRODUCTS LLC
    Product Code
    KXF
    UDI-DI
    00618029831187
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOT INFORMATION AND PHOTOGRAPHS OF THE AFFECTED DEVICE WERE PROVIDED TO AID IN THE INVESTIGATION. THE AFFECTED DEVICE WAS DISCARDED AFTER THE PROVIDED PHOTOGRAPHS WERE TAKEN. A VISUAL/FUNCTIONAL INSPECTION WAS PERFORMED ON THE PROVIDED PHOTOGRAPH OF THE AFFECTED SWAB. THE PHOTOGRAPH SHOWS A SWAB WITH THE TOP PART OF THE FOAM MISSING CONSISTENT WITH THE INFORMATION PROVIDED STATING THAT THE PATIENT BIT DOWN ON THE SWAB. THE PLASTIC STICK APPEARS TO BE INTACT, INDICATING THAT ONLY THE FOAM DISENGAGED FROM THE SWAB. A PRODUCT HISTORY REVIEW WAS PERFORMED FOR THE COMPONENTS WITHIN THE AFFECTED DEVICE'S LOT. WORK ORDERS FOR THIS LOT WERE UNRELATED TO THE INTEGRITY OF THE FOAM. ALL QUALITY CHECKS PERFORMED INDICATED PASSING RESULTS AND ALL RELEASE CRITERIA WERE MET PER THE PRODUCT DRAWING. IN PROCESS QUALITY CHECKS ARE PERFORMED EVERY TWO (2) HOURS AND COULD POTENTIALLY IDENTIFY DEFECTS WITH THE COMPONENTS. A LABELING REVIEW WAS PERFORMED FOR THE AFFECTED FINISHED GOOD. THE OUTER BAG PROVIDES THE FOLLOWING WARNING: "DO NOT ALLOW PATIENT TO BITE DOWN ON THE ORAL CARE TOOL. USE A BITE BLOCK IF PATIENT HAS ALTERED LEVELS OF CONSCIOUSNESS OR CANNOT COMPREHEND COMMANDS. USE CAUTION WITH CHILDREN AND UNRESPONSIVE INDIVIDUALS. FAILURE TO FOLLOW THESE SAFETY PRECAUTIONS MAY DAMAGE THE DEVICE AND PRESENT A CHOKING/ASPIRATION HAZARD. MAY NOT FUNCTION AS INTENDED/POTENTIAL RISK OF CROSS-CONTAMINATION IF DEVICE IS REUSED." THE ROOT CAUSE IS DUE TO CUSTOMER MISUSE SINCE A BITE BLOCK WAS NOT IN USE AND THE PATIENT BIT DOWN ON THE DEVICE.

    Description of Event or Problem · 0

    REPORT RECEIVED OF ORAL SWAB DISENGAGEMENT. REPORTER STATED A MALE PATIENT OF UNKNOWN AGE WAS ADMITTED TO THE FACILITY FOR HYPOXIC BRAIN INJURY RELATED TO A SUICIDE ATTEMPT BY HANGING. THE PATIENT WAS INITIALLY ADMITTED TO THE CRITICAL CARE UNIT, WHERE A TRACHEOSTOMY WAS PLACED. HE WAS SUBSEQUENTLY TRANSFERRED TO THE SPIRITUAL CARE UNIT, WHERE THE REPORTED ORAL SWAB DISENGAGEMENT OCCURRED. THE PATIENT WAS RECEIVING TUBE FEEDINGS, WAS NOT TAKING ANYTHING BY MOUTH, AND WAS EXPERIENCING DECREASED BRAIN ACTIVITY ON ADMISSION TO THE SPIRITUAL CARE WARD. THE PATIENT WAS NOT ALERT OR ORIENTED. THE REPORTER DESCRIBED THE PATIENT AS VERY SEDATE AND NON-REACTIVE. ON (B)(6) 2025, THE PATIENT WAS RECEIVING ORAL CARE WITH AN ORAL SWAB FROM THE #4 MOUTHCARE PACK IN THE 6964-X KIT. THE PATIENT BIT DOWN ON THE FOAM HEAD AND THE TOP PIECE OF THE FOAM HEAD, ABOVE THE STICK, BECAME DISENGAGED INTO THE PATIENT¿S ORAL CAVITY. THE STICK DID NOT BREAK. PHOTOS WERE PROVIDED. STAFF WERE NOT USING A BITE BLOCK AT THE TIME OF THE EVENT. THE EVENT OCCURRED WITH INITIAL USE OF THE ORAL SWAB. THE PATIENT WAS SUBSEQUENTLY COUGHING AND PRODUCING COPIOUS FROTHY SECRETIONS, INDICATING TO STAFF THAT THE PATIENT HAD ASPIRATED THE DISENGAGED FOAM. STAFF PLACED THE PATIENT ON OXYGEN, AND THE PATIENT¿S OXYGEN SATURATIONS REMAINED UNCHANGED. AN EAR, NOSE AND THROAT (ENT) SPECIALIST WAS CALLED TO THE BEDSIDE AND PERFORMED AN ENDOSCOPY WITH A SMALL ENDOSCOPE, ONLY EQUIPPED WITH A CAMERA, AND NOT EQUIPPED WITH THE ABILITY TO RETRIEVE FOREIGN MATERIALS FROM THE BODY. STAFF VISUALIZED THE DISENGAGED FOAM IN THE PATIENT¿S RIGHT BRONCHUS. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO THE OPERATING ROOM (OR), PLACED UNDER GENERAL ANESTHESIA, AND ANOTHER ENDOSCOPY WAS PERFORMED WITH AN ENDOSCOPE EQUIPPED WITH THE ABILITY TO RETRIEVE FOREIGN MATERIALS FROM THE BODY. THE DISENGAGED FOAM WAS RETRIEVED WITH A HOOK LIKE TOOL PASSED THROUGH THE ENDOSCOPE. PER THE REPORTER, THE PATIENT TOLERATED THE PROCEDURE, RECOVERED AS EXPECTED AND HAS NOT HAD ANY OTHER ADVERSE CONSEQUENCES RELATED TO THIS EVENT. THE REPORTER STATED AFTER TAKING THE PHOTOS PROVIDED; THE AFFECTED DEVICE WAS DISCARDED. LOT INFORMATION WAS PROVIDED. NO OTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787782 INTL QCARE RX Q4 SYS W/CORINZ 20 ORAL SWAB KXF SAGE PRODUCTS LLC 6964-X 101439 00618029831187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention