INTL QCARE Q4 SYS W/CORINZ 20

Additional Manufacturer Narrative

THE AFFECTED DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, A PHOTO OF THE AFFECTED DEVICE AND LOT INFORMATION WAS PROVIDED. A VISUAL INSPECTION WAS PERFORMED OF THE PHOTOGRAPH PROVIDED. IN THE PHOTO, IT SHOWS A SUCTION SWAB WHERE THE TOP PART OF THE SWAB AND THE SUCTION STRAW IS MISSING. THE TIP OF THE SUCTION STRAW AND THE FOAM APPEARS TO HAVE A JAGGED EDGE LINING UP WHERE THE PATIENT ALLEGEDLY BIT DOWN ON THE DEVICE. A PRODUCT HISTORY REVIEW WAS PERFORMED. ALL QUALITY CHECKS PERFORMED INDICATED PASSING RESULTS AND ALL RELEASE CRITERIA WERE MET PER THE PRODUCT DRAWING. A LABELING REVIEW WAS PERFORMED. THE LABEL STATES "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 COMPLAINANT STATED THAT THE PATIENT BIT DOWN ON THE SUCTION SWAB CAUSING THE DISENGAGEMENT. THE REPORTED COMPLAINT IS RELATED TO MISUSE AND NOT LIKELY TO BE A QUALITY OR A MANUFACTURING DEFECT.

Description of Event or Problem

REPORT RECEIVED OF A SUCTION SWAB DISENGAGEMENT. A 36-YEAR-OLD-MALE ALERT BUT UNORIENTED PATIENT, WITH A MEDICAL HISTORY OF CEREBRAL INFARCTION, BRAIN DAMAGE, TRACHEOSTOMY WAS ADMITTED TO THE HOSPITAL ON AN UNKNOWN DATE. REPORTER STATED ON (B)(6) 2025, PATIENT WAS RECEIVING ORAL CARE WITH A SUCTION SWAB FROM THE 6464-X KIT. ON INITIAL USE, THE PATIENT BIT DOWN ON THE SWAB RESULTING IN THE TOP PART OF THE SWAB TO BECOME DISENGAGED INTO THE ORAL CAVITY. THE STAFF REMOVED THE DISENGAGED SWAB WITH THEIR FINGERS. REPORTER STATED A BITE BLOCK WAS NOT IN USE AT THE TIME THIS EVENT OCCURRED. THERE WAS NO HARM OR INJURY TO THE PATIENT IN RELATION TO THIS REPORT. THE DEVICE INVOLVED WAS DISCARDED. LOT NUMBER AND PHOTOS OF INVOLVED DEVICE WERE PROVIDED FOR INVESTIGATION. NO OTHER INFORMATION AVAILABLE.