CURITY EYE PD 1-5/8X2-5/8 OVAL STRL

Additional Manufacturer Narrative

SUBMIT DATE: 02/07/2017. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR LOT # 92816100 PRODUCED ON MACHINE EYEPAD. THERE WERE NO MANUFACTURING RELATED ISSUES RELATED TO THE COMPLAINT ISSUED FOR THIS LOT AND THE PRODUCT WAS RELEASE ACCOMPLISHING ALL QUALITY STANDARDS. THIS PRODUCT IS PACKAGED IN A MANUAL PROCESS WHICH HAS NO CTQ SENSORS. DURING IN-FEED PROCESS, THE INDIVIDUAL EYE PADS, COMPRISED OF COTTON SANDWICHED BETWEEN THE GAUZE, ARE DROPPED ONTO THE IN-FEED CONVEYOR AUTOMATICALLY FROM THE AUTOMATED DIE CUTTER. AS THE CONVEYOR APPROACHES THE PACKAGING SECTION OF THE MACHINE, THE OPERATORS SHOULD ASSURE THAT THE EYE PADS ARE CENTERED BETWEEN THE CONVEYOR NOTCHES. SPONGES SHOULD BE NEAT AND SQUARELY PLACED ON THE CONVEYOR TO MINIMIZE THE CHANCES OF GETTING CAUGHT IN THE SEAL. THE IN-FEED OPERATOR SHOULD BE ALERT TO SPONGE QUALITY, DISCARDING DEFECTIVE ONES. THE PACKAGING OPERATOR SHOULD CONTINUALLY CHECK THE PACKAGES DURING MACHINE START UP, ROLL CHANGES, INSPECTION TIME PER DEVICE HISTORY RECORD AND THROUGHOUT THE LOT PROCESS TO ENSURE PAD IN THE SEAL DEFECTS ARE CULL OUT OF THE PROCESS. THIS COMPLAINT WILL BE SHARED WITH THE MANUFACTURING ASSOCIATES TO HEIGHTEN AWARENESS OF THIS DEFECT. NO CHANGES TO THE QUALITY CONTROL SAMPLING PLANS ARE DEEMED NECESSARY. FUNCTIONAL TESTING AND VISUAL INSPECTIONS ARE BEING PERFORMED ACCORDING TO OUR CURRENT QUALITY STANDARDS AND INSPECTION PROCEDURES. SINCE NO COMPLAINT TREND EXISTS, NO FORMAL CORRECTIVE ACTION PREVENTIVE ACTION HAS BEEN CREATED FOR THIS COMPLAINT. THIS COMPLAINT WILL BE USED FOR TRENDING PURPOSES AND REVIEWED WITH PLANT MANAGEMENT.

Description of Event or Problem

IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A EYE GAUZE PAD. THE CUSTOMER STATES: PRIOR TO USE ON A PATIENT, A HOLE WAS FOUND ON THE PACKAGE. NO PATIENT INVOLVEMENT.