Description of Event or Problem · 1
MULTIPLE DATES OF PRODUCT PACKAGING DEFECT FINDS IN 2015 AND 2016. WOUND DRESSING PACKAGING DEFECTS RANGING FROM STERILE PRODUCT STICKING TO INSIDE OF PACKAGING TO PRODUCT THAT SHOULD BE STERILE HANGING OUT OF THE PACKAGING SEAM - EXPOSED AND THEREFORE, NOT STERILE. FIRST REPORT WAS TO COVIDIEN FIELD REP IN 2015, THEN A DIFFERENT FIELD REP IN JULY 2016, THEN TO COVIDIEN QA IN NOVEMBER 2016 - WITH NO RESPONSE RECEIVED ABOUT RECEIPT OR ACTION TAKEN, FROM ANY OF THE COVIDIEN REP OR QA. EARLY DECEMBER 2016, COMPLAINED TO COVIDIEN CUSTOMER SERVICE REP, ON PHONE, GIVING A LIST OF ALL DEFECTS SINCE JULY 2016 (PRODUCT ITEM NUMBERS, LOT NUMBERS, QUANTIFIES AND SPECIFIC DEFECT OF PACKAGING); FINALLY SOMEONE SEEMED TO CARE. I DO STILL HAVE THE DEFECTIVE PRODUCT LAST REPORTED (PRODUCT FOUND FROM LATE JULY 2016 THROUGH CURRENT), BUT DEFECTS FOUND BEFORE JULY 2016 WERE TAKEN BY THE COVIDIEN FIELD REPS. ITEM #3332 X 4PKG; LOT #16G092862 - INK ON PACKAGING, CANNOT TELL IF INSIDE OR OUT; STAFF IN DOUBT, SO DID NOT USE; FOUND 09/28/2016. ITEM #6660 X 1PKG; LOT #16E216762 - INK ON KERLIS WHEN OPENED; STAFF DID NOT USE; FOUND 10/05/2016.