TOC SOS W/PROX 100

Description of Event or Problem

REPORT RECEIVED OF A SUCTION SWAB DISENGAGEMENT. THE REPORTER STATED ON AN UNKNOWN DATE IN (B)(6) 2025, WHILE HE WAS USING A SUCTION SWAB TO PERFORM ORAL CARE FOR HIS SON, A SMALL PIECE OF FOAM DISENGAGED FROM THE SPONGE PORTION OF THE DEVICE AND ENTERED THE PATIENT¿S MOUTH. THE PATIENT WAS DESCRIBED AS A 33-YEAR-OLD MALE WITH A HISTORY OF TRAUMATIC BRAIN INJURY AND ANOXIC BRAIN INJURY. PER THE REPORTER, THE PATIENT WAS ALERT AND ORIENTED BUT NONVERBAL, WITH THE ABILITY TO RELIABLY FOLLOW COMMANDS. THE REPORTER FURTHER STATED THAT THE PATIENT WEIGHED APPROXIMATELY 220 POUNDS AND WAS 6 FEET 3 INCHES TALL. THE REPORTER STATED THE EVENT OCCURRED WITH INITIAL USE OF THE DEVICE. THE REPORTER STATED THAT THE PATIENT DID NOT BITE THE PRODUCT AND THAT NO BITE BLOCK WAS IN USE AT THE TIME OF THE EVENT. THE REPORTER FURTHER STATED THAT THE PATIENT HAD NO ORAL HARDWARE, WAS NOT INTUBATED, AND DID NOT HAVE CHIPPED TEETH THAT COULD HAVE CONTRIBUTED TO THE FOAM DISENGAGEMENT. THE REPORTER STATED THAT THE DISENGAGED PIECE OF FOAM WAS EASILY REMOVED FROM THE PATIENT¿S MOUTH USING SUCTION AND THEIR FINGERS. NO ADVERSE EFFECTS WERE REPORTED. LOT INFORMATION FOR THE AFFECTED DEVICE WAS PROVIDED. THE AFFECTED DEVICE WAS DISCARDED, AND NO SAMPLE PRODUCT WAS RETURNED DESPITE MULTIPLE REQUESTS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

THE DEVICE USED DURING THIS EVENT WAS DISCARDED AND PHOTOS OF THE DEVICE WERE NOT PROVIDED. SAMPLE DEVICES FROM THE SAME LOT WERE ALSO NOT RETURNED. PRODUCT HISTORY RECORDS WERE REVIEWED FOR THE AFFECTED FINISHED GOOD AND LOT. ALL LOTS MET SPECIFICATION AT RELEASE, AND ALL IN PROCESS QUALITY CHECKS PASSED. ALTHOUGH NO DEFECTS WERE IDENTIFIED, SEVERAL WORK ORDERS WERE IDENTIFIED WITHIN SUBCOMPONENT LOTS THAT COULD HAVE CONTRIBUTED TO FOAM DISENGAGEMENT. THESE INCLUDED MACHINE ISSUES RELATED TO EXCESS ADHESIVE APPLICATION AND INCOMPLETE DRILLING, BOTH OF WHICH CAN AFFECT THE BOND STRENGTH BETWEEN THE FOAM HEAD AND THE STRAW. ADDITIONALLY, WORK ORDERS RELATED TO REJECT STATION ISSUES MAY HAVE ALLOWED COMPONENTS WITH ADHESIVE DEFECTS TO PASS THROUGH THE PROCESS. HOWEVER, NO PRODUCT WAS RETURNED AND NO PHOTOS WERE PROVIDED. THEREFORE, A VISUAL AND FUNCTIONAL INSPECTION COULD NOT BE CONDUCTED TO CONFIRM THAT THESE WORK ORDERS WERE RELATED TO THE ROOT CAUSE OF THE REPORTED FOAM DISENGAGEMENT. GIVEN THE ABSENCE OF RETURNED PRODUCT, THE FAILURE MODE CANNOT BE DETERMINED. THEREFORE, THE ROOT CAUSE OF THE FOAM DISENGAGEMENT COULD NOT BE DETERMINED. COMPLAINTS RELATING TO SWAB DISENGAGEMENTS WILL CONTINUE TO BE MONITORED AND TRENDED.