03201 EYE PADS

Additional Manufacturer Narrative

A DEVICE HISTORY RECORD REVIEW OF THE REPORTED LOT NUMBER CONFIRMED THAT THE PRODUCT WAS PRODUCED ACCOMPLISHING QUALITY REQUIREMENTS AND RELEASED ACCORDING TO ESTABLISHED PROCEDURES. A REVIEW OF MAINTENANCE RECORDS (BOTH CORRECTIVE AND PREVENTIVE) AND CALIBRATION RECORDS WERE REVIEWED AND THERE WERE NO ISSUES NOTED. ALL SCHEDULED MAINTENANCE AND CALIBRATION ACTIVITIES WERE COMPLETED ON TIME. THERE WERE NO RELATED PROCESS OR MATERIAL CHANGES RELATED TO THE REPORTED CONDITION FOR THIS PRODUCT OR DESCRIBE CHANGES THAT OCCURRED. (B)(6) SHEETS SHOWED NO ISSUES FOR THE DATE OF PRODUCTION. A REVIEW OF THE MACHINE SETUP WAS CONDUCTED AND NO ISSUES WERE NOTED. PHOTOS WERE PROVIDED FOR SAMPLE ANALYSIS. THE PHOTOS INDICATED A SMALL TEAR IN THE CENTER OF EACH PAD WITHIN THE SEAL TOWARD THE BOTTOM OF THE PACKAGE. THE SAME TEARS ARE SEEN ON MULTIPLE PACKAGES. ON THIS MACHINE, A CHAIN WITH METAL TABS CARRIES THE EYEPAD CUTOUT FROM THE COTTON TOWARD THE PAPER TO BE PACKAGED. AS IT APPROACHES THE AREA TO BE INSERTED BETWEEN THE PAPER, THE METAL TABS ROTATE ALONG A ROLLER AND MOVE OUT OF THE WAY TO NOT MAKE CONTACT WITH THE PAPER. THIS DEFECT COULD HAVE OCCURRED FROM A BENT TAB SUCH THAT IT MADE A SMALL HOLE EVERY SEVERAL TABS. PRIOR TO A LOT¿S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. SPECIFICALLY, PADS ARE VISUALLY INSPECTED FOR HOLES OR TEARS. THE LOT MET ALL DEFINED ACCEPTANCE REQUIREMENTS AND WAS RELEASED. THE TREND FOR THIS COMPLAINT IS LOW. THE MACHINE CURRENTLY DOES NOT HAVE ANY TABS MISALIGNED THAT COULD CAUSE THIS ISSUE. NO FORMAL CORRECTION ACTIONS/PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME. THIS INFORMATION WILL BE UTILIZED FOR TRENDING PURPOSES TO DETERMINE THE NEED FOR ADDITIONAL CORRECTIVE ACTIONS.

Description of Event or Problem

IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH AN EYE GAUZE PAD. THE CUSTOMER REPORTS A TEAR IN THE PACKAGING.