D
Patient 1
ON (B)(6) 2016, (B)(4), MATERIALS MANAGER FOR THE SURGERY CENTER OF (B)(4), REPORTED THAT THE ACCOUNT HAD SOME MORE PROBLEMS WITH THREE BREVI-STF CATHETERS SKIVING/SHEARING. AT THE TIME THIS COMPLAINT WAS ORIGINALLY REPORTED, IT WAS THE SECOND REPORTED COMPLAINT OF ITS KIND FROM THIS ACCOUNT. THE FIRST COMPLAINT (B)(4), WAS INVESTIGATED EARLIER IN THE MONTH AND HAD SINCE BEEN CLOSED. THE MATERIAL MANAGER, (B)(4) REPORTED THAT TWO INCIDENTS OCCURRED, ONE ON (B)(6) 2016, WITH DR. (B)(6) AND ONE ON (B)(6) 2016, WITH DR. (B)(6). ON (B)(6) 2016, THE ACCOUNT RETURNED THREE BREVI-STF CATHETERS AND TWO 15G RK NEEDLES TO EPIMED FOR AN INVESTIGATION. ONCE THE PRODUCTS WERE RETURNED THEY WERE INADVERTENTLY INVESTIGATED AS ONE COMPLAINT (B)(4). HOWEVER, IN LIGHT OF A RECENT FDA INSPECTION THAT OCCURRED FROM MAY 26, 2016, THROUGH JULY 12, 2016, IT WAS DISCOVERED BY FDA INVESTIGATOR, (B)(4), THAT COMPLAINT (B)(4) HAD MULTIPLE REPORTED INCIDENTS FILED WITHIN ONE COMPLAINT. THEREFORE, EPIMED HAS OPENED TWO COMPLAINTS (B)(4) TO DOCUMENT THE EACH REPORTED EVENT SEPARATELY. THE ORIGINAL COMPLAINT (B)(4), WILL REMAIN AN ACTIVE COMPLAINT NUMBER, DUE TO AN MDR (1316297-2016-00002) BEING ASSOCIATED TO THE ORIGINAL COMPLAINT NUMBER. THE ORIGINAL MDR (1316297-2016-00002), FILED WITHIN COMPLAINT (B)(4) WAS UPDATED ON JULY 7, 2016, TO REFLECT THAT THE RK NEEDLE REPORTED ON (B)(6) 2016, TO BE THE MOST LIKELY ROOT CAUSE OF THE REPORTED COMPLAINT. PER (B)(4)'S INVESTIGATION, THERE WAS NO MANUFACTURING FAULT FOUND RELATED TO THE BREVI-STF CATHETERS RETURNED TO (B)(4) ON (B)(6) 2016, AND ALL THE SKIVE/SHEARED CATHETER (FEP) COATING WAS ACCOUNTED FOR. HOWEVER, SINCE THE CLOSURE OF THE ORIGINAL COMPLAINT (B)(4), (B)(4) DISCOVERED THAT THEIR 15G RK NEEDLES WERE NOT PROCESSED PROPERLY AT THE SUPPLIER'S FACILITY. THEREFORE, (B)(4) INITIATED RECALL 1316297-04/20/16-001-R FOR THE 15G RK NEEDLES. THE RECALL NUMBER IS 1316297-042016-001-R. THE RECALL WAS OPENED ON APRIL 20, 2016, AND WAS LATER CLOSED ON MAY 9, 2016. THE RECALL INVOLVED THREE DIFFERENT STERILE LOT NUMBERS (12157181, 12157325, & 12157445), TWO OF WHICH WERE LOT NUMBERS OF 15G RK NEEDLES (100-1415, LOT # 12157325 & LOT# 12157181) THAT WERE SENT TO THE ACCOUNT IN QUESTION. THE RECALL HAS SINCE BEEN CLOSED AND ALL OF THE EFFECTED 15G RK NEEDLES HAVE BEEN RETURNED TO (B)(4) AND DESTROYED. LASTLY, PER (B)(4)'S MOST RECENT COMPLAINT REPORT (B)(4), EPIMED HAS DETERMINED THAT IT IS NECESSARY TO RETROSPECTIVELY FILE A SEPARATE MDR FOR THIS COMPLAINT/EVENT THAT OCCURRED ON (B)(6) 2016. THIS DETERMINATION WAS DUE TO THE FACT THAT IT IS IMPOSSIBLE TO DETERMINE WHICH NEEDLE WAS USED ON WHICH DATE, AND THE FACT THAT BOTH OF THE RETURNED NEEDLES CAUSED SKIVING WHEN TESTED USING EPIMED'S SAMPLE TEST CATHETERS.