(B)(4). NO SAMPLE DEVICE WAS RETURNED AT THE TIME OF THIS REPORT. THERE WAS NO PHOTO FOR REVIEW. THEREFORE NO TESTING OR PHYSICAL EVALUATION WAS ABLE TO BE PERFORMED. A DEVICE HISTORY RECORD REVIEW FOR THE DEVICE LOT NUMBER REPORTED SHOWED NO ISSUES RELATED TO THIS COMPLAINT. ALL TESTING METHODS PERFORMED BY QA ON THIS BATCH WERE FOUND TO BE ACCEPTABLE. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFORMATION RECEIVED. IF THE DEVICE BECOMES AVAILABLE AT A LATER DATE THIS REPORT WILL BE UPDATED ACCORDINGLY.
D
Patient 1
CUSTOMER COMPLAINT ALLEGES THE "ANESTHETIC COULD NOT BE SPRAYED OUT FROM THE ATOMIZER". ALLEGED MALFUNCTION REPORTED TO HAVE OCCURRED DURING USE. A NEW DEVICE WAS USED INSTEAD. IT WAS REPORTED THERE WAS NO MEDICAL INTERVENTION NECESSARY. PATIENT CONDITION WAS REPORTED AS "FINE".
N
Patient 1
(B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED ON THE SAMPLE WAS IT WAS OBSERVED THAT THERE WAS AN OCCLUSION ON THE TIP. FUNCTIONAL TESTING WAS ALSO PERFORMED AND THE OCCLUSION WAS CONFIRMED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT WAS CONFIRMED. THE ROOT CAUSE IS ATTRIBUTED TO EXCESSIVE SOLVENT ON THE TIP, CAUSING A BLOCKAGE OF THE ATOMIZATION HOLE. THIS OPERATION IS DONE MANUALLY, THE ROOT CAUSE IS RELATED TO OPERATOR ERROR. THIS IS CONSIDERED TO BE AN ISOLATED EVENT AS THE PRODUCT WAS MANUFACTURED 29-OCT-2015 AND NO OTHER COMPLAINTS FOR THIS ISSUE HAVE BEEN RECEIVED FROM JUNE 2014 TO PRESENT. A NON-CONFORMANCE WAS OPENED TO ADDRESS THIS ISSUE.
D
Patient 1
CUSTOMER COMPLAINT ALLEGES THE "ANESTHETIC COULD NOT BE SPRAYED OUT FROM THE ATOMIZER". ALLEGED MALFUNCTION REPORTED TO HAVE OCCURRED DURING USE. A NEW DEVICE WAS USED INSTEAD. IT WAS REPORTED THERE WAS NO MEDICAL INTERVENTION NECESSARY. PATIENT CONDITION WAS REPORTED AS "FINE".