450 SAL EJECTOR 3283

Additional Manufacturer Narrative

(B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

IT WAS REPORTED TO COVIDIEN ON (B)(6) 2015 THAT A CUSTOMER HAD AN ISSUE WITH A SALIVA EJECTOR. THE CUSTOMER REPORTS THAT THE BLUE PART CAME OFF IN THE PATIENT'S MOUTH DURING SUCTIONING. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT WAS SEDATED WHEN THIS INCIDENT OCCURRED. THE INCIDENT IS MORE CLEARLY DEFINED BY A COVIDIEN CLINICIAN AS; THE BLUE TIP OF THE SUCTION TUBE CAME OFF DURING ORAL SUCTION. NO MEDICAL INTERVENTION REQUIRED.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD FILE WAS REVIEWED INDICATING THAT PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARD REQUIREMENTS. THERE WERE NO NON-CONFORMING ISSUES REPORTED DURING THE PRODUCTION OF THIS PRODUCT FOR A SIMILAR CONDITION AS REPORTED IN THIS COMPLAINT. THERE WERE 627 SAMPLES RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL INSPECTIONS WERE PERFORMED AND THE REPORTED ISSUE COULD NOT BE CONFIRMED. BECAUSE THE REPORTED ISSUE COULD NOT BE CONFIRMED, A DEFINITE ROOT CAUSE COULD NOT BE CONFIRMED. HOWEVER, A POSSIBLE ROOT CAUSE COULD BE DUE TO THE SAMPLE BEING PACKAGED WITHOUT PASSING THROUGH AN AUTOMATED PULL TEST MACHINE. AS PART OF A CORRECTIVE ACTION, THE PROCESS LAYOUT WAS IMPROVED TO ASSURE THAT THE ASSEMBLY PARTS PASS THROUGH THE AUTOMATED PULL TEST MACHINE 100%. A MEETING WAS CONDUCTED FOR THE MANUFACTURING PERSONNEL TO REINFORCE INFORMATION REGARDING THE USE OF THE PRODUCT AS WELL AS THE REPORTED ISSUE. IF ADDITIONAL INFORMATION IS RECEIVED WARRANTING FURTHER ANALYSIS, THE INVESTIGATION WILL BE RESUMED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.