AN INTERNAL INVESTIGATION HAS BEEN PERFORMED AND IS PRESENTED IN THIS SECTION. ANALYSIS OF DEVICE HISTORY RECORDS: COPAN CHECKED THE INTERNAL RECORDS RELATED TO THE MANUFACTURING AND CONTROLS BEFORE THE RELEASE ON THE MARKET OF THE REPORTED PRODUCT 503CS01, LOT NUMBER YUDC00 ((B)(4) PIECES). NO ANOMALIES HAVE BEEN FOUND. THIS IS THE FIRST EVENT RECEIVED ON THIS LOT. THE INVOLVED DEVICE WAS NOT RETURNED TO COPAN FOR EVALUATION. MECHANICAL SWAB SHAFT BENDING TESTS HAVE BEEN PERFORMED ON THE RETAINED SAMPLES OF THE REPORTED LOT ON THE POINT WHERE THE BREAKAGE OCCURRED, IN ORDER TO TEST SHAFT RESISTANCE TO BREAKAGE. ALL THE SWABS SUBJECTED TO THE BENDING TESTS GAVE CONFORMING RESULTS. THE INTERNAL INVESTIGATION COULD NOT CONFIRM ANY MALFUNCTION OR DEFECT IN THE DEVICE LOT ASSOCIATED WITH THIS INCIDENT. AN ANALYSIS OF THE INCIDENCE OF THE PROBLEM HAS BEEN PERFORMED FROM 2011 UP TO DATE: COPAN RECEIVED (B)(4) WORLDWIDE COMPLAINTS RELATED TO BREAKAGE OF SWAB DURING SAMPLING COLLECTION PROCEDURE FOR PRODUCT CONTAINING THE SAME TYPE OF SWAB. CONSIDERING ALL THESE PRODUCTS SOLD WORLDWIDE FROM 2011 TO HALF 2016, THE FAILURE INCIDENCE IS (B)(4). CONSIDERING THAT THE INTERNAL INVESTIGATION COULD NOT CONFIRM ANY MALFUNCTIONS/DEFECTS IN THE DEVICE LOT ASSOCIATED WITH THIS INCIDENT, THAT TO OUR KNOWLEDGE NO EVENT HAS LED TO SERIOUS MEDICAL CONSEQUENCES SO FAR IN SIMILAR CIRCUMSTANCES (BREAKAGE OF THE SWAB DURING COLLECTION) AND THAT THE INCIDENCE RATE IS VERY RARE, NO CORRECTIVE ACTIONS IS PLANNED AT THIS TIME. AN ONGOING IMPROVEMENT ON THE PRODUCT IN ORDER TO REDUCE THE ALREADY VERY LOW INCIDENCE RATE OF SWAB BREAKAGE IS OPENED. COPAN WILL CONTINUE TO MONITOR PRODUCTS FOR SIMILAR EVENTS. DEVICE NOT RECEIVED.
D
Patient 1
ON 2016/07/20 COPAN RECEIVED AN EMAIL FROM ONE OF ITS DISTRIBUTORS SAYING THAT IN A (B)(6) HOSPITAL (B)(6) YEARS OLD BOY WAS ADMITTED AT 12:17PM ON (B)(6) 2016 WITH DIAGNOSIS OF PNEUMONIA. NASAL PHARYNGEAL SWAB WAS ORDERED AFTER ADMISSION. AT 13:40 PM, THE SWAB STICK WAS CHECKED AND NO VISIBLE DEFECTS WERE NOTICED. IT WAS REPORTED THAT PATIENT WAS CALM AND COOPERATIVE DURING SAMPLING PROCEDURE. AFTER TAKING OUT THE SWAB STICK FROM THE RIGHT NOSTRIL OF THE PATIENT, THE NURSE REALIZED THAT THE FRONT PART OF THE SWAB WAS MISSING (AROUND 4-5CM). IT WAS REPORTED THAT THE CHILD'S VITAL SIGNS WERE STABLE AND NO SHORTNESS OF BREATH WAS REGISTERED. ON (B)(6) 2016 COPAN SENT A QUESTIONNAIRE TO THE DISTRIBUTOR IN ORDER TO ACQUIRE MORE INFORMATION ABOUT THE EVENT. ON 2016/08/02 COPAN RECEIVED THE QUESTIONNAIRE FILLED IN. DETAILS ABOUT THE EVENT WERE BASICALLY CONFIRMED: THE SWAB WAS INSERTED INTO THE PATIENT'S NASAL PASSAGE. SWAB WAS HELD FOR 5 SECONDS TO ALLOW ABSORPTION OF SECRETION, FOLLOWED BY GENTLE ROTATION 2 - 3 TIMES TO COLLECT CELLS. WHEN THE SWAB WAS REMOVED FROM NOSTRIL, THE SWAB STICK WAS NOTED TO HAVE SHORTENED BY 5CM AND THE MISSING PART COULD NOT BE FOUND. NO EXTERNAL INJURY WAS NOTED. AFTER THE EVENT, ENT SURGEON WAS CONSULTED URGENTLY AND ANTERIOR RHINOSCOPY WAS PERFORMED: NO FOREIGN BODY COULD BE SEEN IN THE UPPER AIRWAYS. X-RAY NECK, CHEST AND ABDOMEN WERE DONE WITH NO ABNORMALITY NOTED. THE PATIENT'S CONDITION WAS CLOSE MONITORED INCLUDING SAVING STOOL FOR INVESTIGATION OVER A WEEK. THE BROKEN SWAB STICK COULD NOT BE FOUND. THE PATIENT'S CONDITION WAS STABLE AND, SO HE WAS DISCHARGED ON (B)(6) 2016.