DUE TO MISSING INFORMATION ON THE PART AND ON THE LOT NUMBER INVOLVED, IT IS NOT POSSIBLE TO COMPLETE AN INTERNAL INVESTIGATION. AN ANALYSIS OF THE INCIDENCE OF THE PROBLEM HAS BEEN PERFORMED FROM 2011 TO 2017: COPAN RECEIVED (B)(4) WORLDWIDE COMPLAINTS RELATED TO BREAKAGE OF SWAB DURING SAMPLING COLLECTION PROCEDURE FOR PRODUCT CONTAINING THE SAME COMPONENT AS # (B)(4). CONSIDERING ALL THESE PRODUCTS SOLD WORLDWIDE FROM 2011 TO 2017 THE FAILURE INCIDENCE (FLOQSWABS A305CS01 BREAKAGE DURING SAMPLING) IS (B)(4). CONSIDERING THAT THE PATIENT CONDITION HAS BEEN DESCRIBED AS NOT CRITICAL, THAT NO EVENT HAS LED TO SERIOUS MEDICAL CONSEQUENCES SO FAR IN SIMILAR CIRCUMSTANCES (BREAKAGE OF THE SWAB DURING COLLECTION) AND THAT THE FAILURE RATE IS VERY LOW, NO FURTHER ACTION IS PLANNED AT THIS TIME. COPAN WILL CONTINUE TO MONITOR PRODUCTS FOR SIMILAR EVENTS AND WILL REOPEN THE ASSESSMENT OF THIS COMPLAINT IF ADDITIONAL INFORMATION WILL BE RECEIVED FROM THE HOSPITAL.
D
Patient 1
A REPORT WAS SENT BY THE INITIAL REPORTER TO FDA (MEDWATCH# (B)(4)). COPAN DIAGNOSTICS AS COPAN FLOCK TECHNOLOGIES US AGENT BECAME AWARE OF THE EVENT ON 01/30/2018. THE MEDWATCH FROM FDA WAS RECEIVED IN COPAN DIAGNOSTICS' MAILBOX AS FIRST AND SOLE NOTIFICATION OF THE EVENT. THE DESCRIPTION OF THE EVENT IN THE REPORT SUBMITTED BY THE USER WAS AS FOLLOWS: "WHILE SWABBING THE PATIENT'S RIGHT NOSTRIL WITH A FLU SWAB USING APPROPRIATE TECHNIQUE, UPON REMOVING THE SWAB FROM THE NOSTRIL, IT WAS NOTICED THAT THE END OF THE SWAB BROKE OFF IN THE PATIENT'S NOSE AND REMAINED IN THE NOSTRIL. PATIENT WAS INSTRUCTED TO BLOW OUT THE NOSE IN AN ATTEMPT TO REMOVE THE SWAB. UPON EXAMINATION, NO FOREIGN BODY WAS NOTED OR ABLE TO BE RETRIEVED. PATIENT WAS SENT TO AN ENT AND THE SWAB WAS RETRIEVED BY THE ENT". THE MEDWATCH OF THE HOSPITAL MENTIONED NEITHER THE PRODUCT PART NUMBER NOR THE LOT NUMBER INVOLVED. THE REPORTED PART NUMBER # A305CS01 IS A PART NUMBER OF A FLOCKED SWAB (COMPONENT) OF SEVERAL DIFFERENT KITS (FINISHED PRODUCTS). ON 01ST FEB 2018 COPAN CONTACTED MS. (B)(6) (INITIAL REPORTER AND SYSTEM QUALITY MANAGER OF THE HOSPITAL) BY EMAIL ASKING DETAILS ON THE PRODUCT INVOLVED AND SENDING A QUESTIONNAIRE FOR FURTHER INVESTIGATE THE EVENT. MS (B)(6) ANSWERED THAT SHE HAD REACHED OUT THE TEAM AND THEY WILL ANSWER AS SOON AS POSSIBLE. FURTHER TO THE FIRST ATTEMPT, COPAN MADE 4 ADDITIONAL ATTEMPTS (ON THE 07TH FEB 2018, 08TH FEB 2018, ON 13TH FEB 2018 BY EMAIL AND ON THE 22ND FEB 2018 BY PHONE, LEAVING A MESSAGE ON THE VOICEMAIL). NO ADDITIONAL INFORMATION WAS RECEIVED BY COPAN FROM THE HOSPITAL TILL NOW.