450 SAL EJECTOR 3283

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEY HAVE A SAFETY ISSUE WITH A PRODUCT THAT IS USED DAILY IN THEIR GASTROINTESTINAL (GI) PROCEDURES. PER CUSTOMER, THIS IS A SALIVA EJECTOR THAT IS USED TO SUCK OUT THE SALIVA OUT OF A PATIENT¿S MOUTH WHILE THEY ARE SEDATED, MUCH LIKE A DENTIST¿S OFFICE, UNFORTUNATELY, THE SMALL PLASTIC BLUE PIECE HAS BEEN FALLING OFF VERY EASILY. THE ISSUE WAS NOTICED WHEN USED ON A PATIENT. THERE WAS NO PATIENT HARM REPORTED. THE CUSTOMER FURTHER STATED THAT THEY ARE STILL USING THE PRODUCT WITH A NEW PROTOCOL AROUND PULLING ON THE BLUE TIP FIRST TO MAKE SURE IT¿S SEATED AND NOT LOOSE.

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Additional Manufacturer Narrative

A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER WAS NOT RECEIVED WITH THE COMPLAINT. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. A SAMPLE WAS NOT RECEIVED FOR THE INVESTIGATION. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM A FOLLOW UP INVESTIGATION TO INCLUDE FUNCTIONAL AND VISUAL EVALUATIONS TO CONFIRM THE ISSUE AND ROOT CAUSE ANALYSIS. AT THIS TIME, A CORRECTIVE AND PREVENTIVE ACTION IS NOT DEEMED NECESSARY. THE CURRENT PROCESS IS RUNNING ACCORDING TO PRODUCT SPECIFICATIONS, MEETING ALL QUALITY ACCEPTANCE CRITERIA. WE WILL KEEP MONITORING THE PROCESS FOR ANY ADVERSE TRENDS THAT REQUIRE IMMEDIATE ATTENTION. THIS COMPLAINT WILL BE USED FOR QA TRACKING AND TRENDING PURPOSES.