ESWAB¿ COLLECTION KIT

Additional Manufacturer Narrative

A SIMILAR ISSUE HAD PREVIOUSLY BEEN REPORTED, THROUGH A COMPLAINT RECEIVED FROM US DISTRIBUTOR OF DEVICE REF. 220245, IN EARLY MAY 2026, FOR LOT N. N50185900. BASED ON INTERNAL ASSESSMENT AND AS NO CLEAR DESCRIPTION OF THE CLAIMED CONDITION WAS AVAILABLE AT THAT TIME, THE COMPLAINT WAS CLOSED WITH NO CONFIRMED DEVICE DEFECT. THEN, THE MDR RECEIVED FROM FDA REFERRED TO MULTIPLE LOT NUMBERS, INCLUDING LOT N. N50185900; HOWEVER, TWO OF THE REPORTED LOT NUMBERS WERE INITIALLY UNCLEAR OR INCORRECTLY TRANSCRIBED. THROUGH COLLABORATION WITH US DISTRIBUTOR OF DEVICE REF. 220245, COPAN IDENTIFIED THE CLAIMED LOTS AS N50196400, N50205600 AND N50185900. SUBSEQUENTLY, COPAN DIRECTLY CONTACTED THE MDR SUBMITTER (FROEDTERT HOSPITAL) TO ASK FOR BOTH EVIDENCE AND ADDITIONAL DETAILS OF THE CLAIMED CONDITION. THE MDR SUBMITTER PROVIDED COPAN WITH A VIDEO, CLEARLY SHOWING THE CLAIMED CONDITION FOR LOT N. N50196400. TO DATE, PRELIMINARY INVESTIGATION ACTIVITIES, INFORMATION RECEIVED BY THE MDR SUBMITTER, AND SUBSEQUENT FOLLOW-UP ACTIVITIES ALLOWED COPAN TO VERIFY THE FOLLOWING. - FOUR LOTS HAVE BEEN IDENTIFIED BY THE MDR SUBMITTER AS AFFECTED BY THE CLAIMED CONDITION: N50196400, N50205600, N50185900, AND N50255300. - NO OTHER SIMILAR COMPLAINTS/NOTIFICATIONS HAVE BEEN RECEIVED FROM THE MARKET TO DATE. - THE ISSUE IS RELATED TO A SLIGHTLY REDUCED PEEL TAB. NO PATIENT IMPACT HAS BEEN REPORTED BY THE MDR SUBMITTER AND BASED ON THE AVAILABLE INFORMATION, NO PATIENT IMPACT HAS BEEN IDENTIFIED AS ASSOCIATED WITH THIS ISSUE. - AT THIS STAGE, THE ISSUE HAS BEEN CONFIRMED FOR LOT N50196400 BASED ON AVAILABLE OBJECTIVE EVIDENCE (VIDEO). THEREFORE, THIS REPORT IS BEING SUBMITTED FOR THIS SPECIFIC LOT. RETAIN SAMPLES OF LOT N50196400 SHOW A SLIGHTLY REDUCED PEEL TAB. THE SAME SAMPLES HAVE BEEN CHECKED FOR SEALING CORRECTNESS AND TESTED FOR POUCH OPENING AND RESULTED IN COMPLIANCE: EVEN IF THE POUCHES SHOW LIMITED SURFACE AREA TO GRASP AND PEEL THE POUCH, THE POUCHES CAN BE CORRECTLY PEELED AND OPENED. ALL CLAIMED LOTS ARE CURRENTLY UNDER INVESTIGATION TO CLEARLY ASSESS THE NATURE OF THE ISSUE AND ITS APPLICABILITY TO THE 3 LOTS, IF ANY. THE INTERNAL INVESTIGATION INCLUDES TESTS ON RETAIN SAMPLES AND REVIEW OF PRODUCTION RECORDS. UPDATES WILL BE PROVIDED AS SOON AS NEW INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

ON 2026/05/11, COPAN RECEIVED FROM FDA MEDICAL DEVICE REPORT (MDR) # (B)(4). THE MDR DEALS WITH COPAN ESWAB® DEVICE (REF. 220245), WHICH CONSISTS OF A STERILE PACKAGE CONTAINING A SCREW-CAP TUBE FILLED WITH LIQUID AMIES TRANSPORT MEDIUM AND A SPECIMEN COLLECTION SWAB. THE STERILE PACKAGE IS A PLASTIC FILM POUCH, DESIGNED TO BE OPENED BY PEELING AT THE DEDICATED AREA (PEEL TAB). THE AREA IS INDICATED WITH PRINTED INFORMATION ("PEEL HERE"). THE AREA IS POSITIONED AND DESIGNED TO OPEN THE POUCH IN A MANNER THAT ALLOWS THE USER TO GRASP THE SWAB FROM ITS PROXIMAL END, WITHOUT TOUCHING THE SWAB TIP. RECEIVED MDR INCLUDES THE FOLLOWING INFORMATION: - "SWABS ARE NOT OPENING AS EASILY AS THEY NORMALLY DO", - "IT DOES APPEAR THAT LOT N5020566, 03061065-LOT N50196400 AND 0306689 LOT N 501185900 SEEM TO HAVE THE PLASTIC WRAPPER UPSIDE DOWN, SO THE EASIER PART TO OPEN IS AT THE BOTTOM AND NOT AT THE TOP AS INDICATED", - "PROVIDERS AND MY STAFF ARE HAVING TO USE SCISSORS AT TIMES TO OPEN THEM.", - "NO PATIENTS HAVE BEEN IMPACTED THAT I AM AWARE OF. JUST PROVIDERS REPORTING THE CONCERN OF THE PRODUCT NOT WORKING AS IT NORMALLY HAS WHEN OPENING." BASED ON INFORMATION COLLECTED DURING INVESTIGATIONS OF THIS CASE, COPAN VERIFIED THAT THE CLAIMED DEVICES ARE NOT WRAPPED UPSIDE-DOWN AND THAT THE PEEL TAB IS CORRECTLY POSITIONED AND IDENTIFIED. INSTEAD, THE CLAIMED CONDITION CONSISTS IN THE FACT THAT THE PEEL TAB MAY BE REDUCED, POTENTIALLY RESULTING IN INCREASED DIFFICULTY IN INITIATING THE POUCH OPENING, AS THE USER MAY HAVE LIMITED SURFACE AREA TO GRASP AND PEEL THE POUCH.