450 SAL EJECTOR 3283

Additional Manufacturer Narrative

A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE A LOT NUMBER WAS NOT PROVIDED. MANUFACTURING RECORDS ARE ROUTINELY REVIEWED PRIOR TO THE RELEASE OF PRODUCT TO ENSURE PROCESS AND PRODUCT COMPLIANCE. ONE SAMPLE WITHOUT THE ORIGINAL PACKAGE OR LOT NUMBER WAS RECEIVED FOR EVALUATION. AFTER PERFORMING VISUAL INSPECTION, THE ISSUE WAS OBSERVED; THE BLUE TIP WAS DETACHED, CONFIRMING THE REPORTED ISSUE. THE ROOT CAUSE ANALYSIS FROM THE SAMPLE ANALYSIS AND THE PHYSICAL EVIDENCE OBSERVED THERE WAS NO ADHESIVE RESIDUE. IT WAS DETERMINED THAT THE MOST PROBABLE ROOT CAUSE WAS GUN WEAR ON THE DISPENSER THAT RESULTED IN NO ADHESIVE IN THE SALIVA EJECTOR TIP. AS A CORRECTIVE ACTION, THE MACHINE EXTRUDER PERFORMS A 100% AUTOMATED ASSEMBLY OF THE BLUE TIP. THE ABOVE MENTIONED ACTIONS WERE IMPLEMENTED HOWEVER, WITHOUT A LOT NUMBER IT CANNOT BE DETERMINED IF THE SPECIFIC DEVICE THAT FAILED PER THIS CUSTOMER COMPLAINT WAS MANUFACTURED PRIOR OR AFTER THE ACTIONS TAKEN. THE GAIN KIT DISPENSER WAS CHANGED (B)(6)-2015. THE MAINTENANCE OF THE GAIN KIT DISPENSER WAS INCLUDED TO PERFORM MAINTENANCE PERIODICALLY. ANY ADDITIONAL CORRECTIVE AND PREVENTATIVE ACTIONS ARE DEEMED NOT APPLICABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED WARRANTING FURTHER ANALYSIS, THE INVESTIGATION WILL BE RESUMED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDER WAY; 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 STATES PRIOR TO USE ON A PATIENT, THE BLUE TIP CAME OFF OF THE SALIVA EJECTOR AND WAS FOUND INSIDE THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.