TRANSYSTEM¿ / CULTURESWAB¿
Report
- Report Number
- 3002444944-2023-00001
- Event Type
- Malfunction
- Date Received
- July 2, 2024
- Report Date
- July 2, 2024
- Manufacturer
- COPAN ITALIA SPA
- Product Code
- JSM
- PMA / PMN Number
- K946283
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
A TOTAL OF 6 COMPLAINTS HAVE BEEN RECEIVED UP TO DATE RELATED TO THE SAME PRODUCT CODE (900-0370, UDI-DI: (B)(4)) AND 1 ADDITIONAL COMPLAINT HAS BEEN RECEIVED ON PRODUCT CODE 220148 (UDI-DI: (B)(4)). ALL THE REGISTERED COMPLAINTS REFER TO THE SAME SUSPECTED MALFUNCTION. THIS REPORT REFERS TO THE FOLLOWING PRODUCT CODES, LOT NUMBERS, AND RELATED EXPIRATION DATES: 900-0370 - 221122800 - 12/31/2023; 900-0370 - 221973300 - 03/31/2024; 900-0370 - 221122200 - 12/31/2023; 900-0370 - 230397900 - 07/30/2024; 900-0370 - 230065900 - 06/13/2024; 900-0370 - 230627500 - 08/04/2024; 220148 - 230627100 - 04/29/2024. THE CLAIMED PRODUCT IS A COLLECTION AND PRESERVATION SYSTEM OF HUMAN SPECIMENS, COMPOSED OF A PLASTIC CAP/TUBE FILLED WITH PRESERVATION MEDIUM AND TWO FIBER SWABS FOR THE SPECIMEN COLLECTION. THE INTERNAL INVESTIGATION IS ONGOING AND TAKES INTO ACCOUNT THE WHOLE RECEIVED COMPLAINTS. COPAN IS CURRENTLY WORKING ON HISTORICAL DATA ANALYSIS, RETAINS INSPECTIONS, DOCUMENTAL REVIEWS, AND INSPECTION OF THE RECEIVED SAMPLES. MOREOVER, COPAN IS WAITING FOR ADDITIONAL INFORMATION TO BE RETRIEVED BY THE INVOLVED DISTRIBUTOR (CEPHEID, INC.), NEEDED TO EVALUATE THE ISSUE, INCLUDING DETAILS REGARDING THE HANDLING OF THE PRODUCT MADE BY THE COMPLAINANT. A FOLLOW-UP MDR WILL BE PROVIDED WITH UPDATED INVESTIGATION FINDINGS. NOTE: THIS REPORT SUBMISSION WAS TEMPTED BY COPAN ON 13TH DEC 2023. TODAY (02ND JULY 2024) COPAN IS SENDING A COPY OF WHAT WAS SUBMITTED ON 13TH DEC 2023, SINCE COPAN BECOMES NOW AWARE THAT THE REPORT INCLUDED A DIGITS ERROR IN THE FEI NUMBER. THEREFORE, THE ISSUE IS NOW BEEN CORRECTED AND THIS IS A RESUBMISSION.
A TOTAL OF 7 COMPLAINTS HAVE BEEN RECEIVED UP TO DATE RELATED TO THE SAME PRODUCT CODE (900-0370, UDI-DI: (B)(4)), 1 COMPLAINT HAS BEEN RECEIVED ON PRODUCT CODE 220148 (UDI-DI: (B)(4)), AND 1 COMPLAINT ON PRODUCT CODE 220109 (UDI-DI: (B)(4)). ALL THE REGISTERED COMPLAINTS UP TO DATE REFER TO THE SAME SUSPECTED MALFUNCTION (LEAKING ISSUE) AND ALL THE CLAIMED PRODUCTS DIFFER ONLY FOR LABELLING CUSTOMIZATIONS. BELOW AN UPDATED LIST OF THE CLAIMED PRODUCT CODES, LOT NUMBERS, AND RELATED EXPIRATION DATES IS PROVIDED: 900-0370 - 221122800 - 12/31/2023, 900-0370 - 221973300 - 03/31/2024, 900-0370 - 221122200 - 12/31/2023, 900-0370 - 230397900 - 07/30/2024, 900-0370 - 230065900 - 06/13/2024, 900-0370 - 230627500 - 08/04/2024, 900-0370 - 230535300 - 07/14/2024 (NEW), 220148 - 230627100 - 04/29/2024, 220109 - 222088600 - 04/30/2024 (NEW). UP TO DATE, THE INTERNAL INVESTIGATION ACTIVITIES RETURNED THE FOLLOWING: DOCUMENTAL REVIEWS (BHR OF ALL CLAIMED LOTS, REGISTRATIONS OF PLANNED AND EXTRAORDINARY MAINTENANCE ACTIVITIES CARRIED OUT ON THE MACHINES INVOLVED IN THE CLAIMED PRODUCTS' MANUFACTURING, REPORTS OF THE EXISTING IN PROCESS CONTROLS, ANALYSIS OF DETECTED NONCONFORMITIES ON RAW MATERIALS INVOLVED IN THE CLAIMED PRODUCTS MANUFACTURING, AND CHANGES ANALYSIS): NO ANOMALIES NOR CRITICALITIES HAVE BEEN DETECTED. RETROSPECTIVE ANALYSIS OF RECEIVED COMPLAINTS ON ANALOGOUS PRODUCTS: SO FAR, NO COMPLAINTS FOR THE SAME ISSUE HAVE BEEN RECEIVED FROM USERS OTHER THAN THE ONES INVOLVED IN THESE CASES. ADDITIONAL INVESTIGATION ACTIVITIES HAVE BEEN INITIATED AND ARE STILL ONGOING. THEIR OUTCOMES WILL BE PROVIDED IN THE NEXT FOLLOW UP MDR (EXPECTED DATE OF THE NEXT REPORT: 01/22/2024). NOTE: THIS REPORT SUBMISSION WAS TEMPTED BY COPAN ON 10TH JAN 2024. TODAY (02ND JULY 2024) COPAN IS SENDING A COPY OF WHAT WAS SUBMITTED ON 10TH JAN 2024, SINCE COPAN BECOMES NOW AWARE THAT THE REPORT INCLUDED A DIGIT ERROR IN THE FEI NUMBER. THEREFORE, THE ISSUE IS NOW BEEN CORRECTED AND THIS IS A RESUBMISSION.
AS PER SECOND FOLLOW UP REPORT OF 01/22/2024: THE INTERNAL INVESTIGATION ACTIVITIES LED TO EXCLUDE THE PRODUCT PLASTIC COMPONENTS (TUBES, CAPS, AND SWABS APPLICATOR, AS REPORTED IN) AS POSSIBLE ROOT CAUSE OF THE ISSUE. ON TESTED RETAIN SAMPLES, LEAKAGE WAS DETECTED ONLY FOR THOSE TUBES WHERE THERE WAS VISIBLE FREE LIQUID MEDIUM (I.E., NOT HELD BY THE SPONGE) IN THE TUBE AFTER INSERTING THE SWABS IN THE TUBE ITSELF ("AFTER THE USE" CONFIGURATION), AND WHEN KEEPING THESE SAME TUBES UPSIDE DOWN. THE REVIEW OF THE INVOLVED PRODUCTS' DESIGN DOCUMENTATION CONFIRMED THAT THE CAP-TUBE ASSEMBLY CAN FUNCTION AS A TRANSPORT CONTAINER IN THE "AFTER THE USE" CONFIGURATION ONLY WHEN THERE IS NO FREE LIQUID MEDIUM IN THE TUBE. THEREFORE, ADDITIONAL TESTS ON INVOLVED PRODUCTS HAVE BEEN CARRIED OUT TO INVESTIGATE THE MANUFACTURING PROCESS, IN ORDER TO VERIFY THE PRESENCE OF FREE LIQUID MEDIUM IN THE "AFTER THE USE" CONFIGURATION AS POSSIBLE ROOT CAUSE OF THE LEAKAGE. THESE TESTS LED TO IDENTIFY THE ROOT CAUSE OF THE ISSUE AS THE PRESENCE OF FREE LIQUID, DUE TO HIGH FILLING VOLUME, WITH SUBSEQUENT LEAKAGE WHEN THE PRODUCT IS KEPT UPSIDE-DOWN. A CORRECTIVE ACTION TO BE APPLIED TO TRANSYSTEM¿ 139CFA, 8139CQ/BD, AND 8139CBD.US HAS BEEN EVALUATED AS NEEDED; THEREFORE, A CAPA HAS BEEN INITIATED AND IS CURRENTLY ONGOING. THIS ACTION FOCUSES ON LIQUID MEDIUM DOSAGE TO AVOID LEAKAGE AFTER INSERTING THE SWABS INTO THE TUBE WITH THE MEDIUM/SPONGE. COPAN HAS TAKEN INTO ACCOUNT THE FOLLOWING: - NO REPORTS OF ANY CONSEQUENT CLINICAL SIGN, SYMPTOM, OR CONDITION ON THE RECALLED PATIENTS OR USERS HAVE BEEN RECEIVED. - BASED ON THE AVAILABLE AND ON COLLECTED INFORMATION FROM THE MARKET UP TO DATE, THE ISSUE OCCURRENCE DOES NOT EXCEED THE ACCEPTABILITY LIMITS FOR THE RISKS IDENTIFIED AS ASSOCIATED TO THIS DEVICE ISSUE. - BASED ON THE AVAILABLE AND ON COLLECTED INFORMATION UP TO DATE, THIS ISSUE IS CONFIRMED AS AN ISOLATED CASE. BASED ON THE ABOVE-DESCRIBED CONSIDERATIONS, COPAN HAS EVALUATED THAT NO FIELD ACTION IS NEEDED. NOTE: THIS REPORT SUBMISSION WAS TEMPTED BY COPAN ON 13TH MAR 2024. TODAY (02ND JULY 2024) COPAN IS SENDING A COPY OF WHAT WAS SUBMITTED ON 13TH MAR 2024, SINCE COPAN BECOMES NOW AWARE THAT THE REPORT INCLUDED A DIGIT ERROR IN THE FEI NUMBER. THEREFORE, THE ISSUE IS NOW BEEN CORRECTED AND THIS IS A RESUBMISSION.
THE DEVICES INVOLVED IN THIS ISSUE (PRODUCT CODES 900-0370, 220148, AND 220109) ARE COMPOSED OF A STERILE PEEL POUCH CONTAINING A SWABS APPLICATOR AND A TUBE; THIS LATTER INCORPORATES THE TRANSPORT MEDIUM (LIQUID STUART) HELD IN A SPONGE. IN ADDITION TO WHAT HAS BEEN REPORTED IN THE FIRST FOLLOW UP OF 01/10/2024, THE FOLLOWING INVESTIGATION ACTIVITIES HAVE BEEN COMPLETED: - PLASTIC COMPONENTS (TUBES, CAPS, AND SWABS APPLICATOR) ANALYSIS AND TESTS: PERFORMED DIMENSIONAL AND GEOMETRY CHECKS, ABSORPTION CHECKS, AND DEFORMITY ABSENCE CONTROLS LED TO EXCLUDE ISSUES IN PLASTIC COMPONENTS AS POSSIBLE ROOT CAUSE OF THE DETECTED LEAKING. - RETAINS AND RECEIVED SAMPLES (SAMPLES OF LOT NUMBERS 230065900 AND 221122200, RECEIVED BY USER MARYLAND DEPT. OF HEALTH) TESTS: LEAKAGE HAS BEEN DETECTED ONLY FOR THOSE TUBES WHERE THERE WAS VISIBLE FREE LIQUID MEDIUM IN THE TUBE AFTER INSERTING THE SWABS IN THE TUBE ITSELF, AND WHEN KEEPING THESE SAME TUBES UPSIDE DOWN. INDEED, AS THE SWABS APPLICATOR IS INSERTED INTO THE TUBE, THE SPONGE COMPRESSES DOWN, LETTING THE LIQUID MEDIUM DRAW INTO THE SWABS TIP BY CAPILLARY ACTION. - REVIEW OF THE DESIGN AND VALIDATION DOCUMENTATION: IT HAS BEEN NOTED THAT THE INVOLVED PRODUCTS SHOULD NOT SHOW FREE LIQUID MEDIUM IN THEIR "AFTER THE USE" CONFIGURATION (I.E., WHEN THE SWABS ARE INSERTED IN THE TUBE CONTAINING THE SPONGE). THIS FIRST PART OF THE INVESTIGATION LED TO FOCUS ON THE REMAINING COMPONENTS (SPONGE AND LIQUID MEDIUM) AS POSSIBLE ROOT CAUSE OF THE ISSUE. THEREFORE, CURRENTLY ADDITIONAL TESTS ON INVOLVED PRODUCTS ARE ONGOING: THESE TESTS HAVE THE AIM TO EVALUATE THE MANUFACTURING PROCESS AND THE DEVICES' COMPONENTS (SPONGE AND LIQUID MEDIUM). OUR NEXT FOLLOW-UP WILL PROVIDE RESULTS OBTAINED ON SAMPLES WHEN TESTED FOR LEAKAGE. THE NEXT REPORT WILL BE PROVIDED WITHIN 03/18/2024. NOTE: THIS REPORT SUBMISSION WAS TEMPTED BY COPAN ON 22ND JAN 2024. TODAY (02ND JULY 2024) COPAN IS SENDING A COPY OF WHAT WAS SUBMITTED ON 22ND JAN 2024, SINCE COPAN BECOMES NOW AWARE THAT THE REPORT INCLUDED A DIGIT ERROR IN THE FEI NUMBER. THEREFORE, THE ISSUE IS NOW BEEN CORRECTED AND THIS IS A RESUBMISSION.
ON 9TH NOVEMBER 2023, COPAN DIAGNOSTICS, INC. (US AGENT OF COPAN ITALIA SPA - HEREAFTER, COPAN) HAS BEEN INFORMED BY CEPHEID, INC. (HEREAFTER, DISTRIBUTOR) ABOUT AN ISSUE INVOLVING COPAN PRODUCT 900-0370. THE EVENT HAS BEEN DESCRIBED AS FOLLOWS BY THE DISTRIBUTOR, BASED ON THE INFORMATION THE DISTRIBUTOR RECEIVED BY A COSTUMER OF THEIRS (HEREAFTER, USER): "CUSTOMERS HAVE BEEN REPORTING LEAKING TUBES. THEY SUSPECT THAT THE LID IS NOT SCREWED ON PROPERLY BECAUSE THE LABEL IS PLACED TOO HIGH ON THE TUBE (SEE PICTURE AND INFO BELOW). WAS THERE A LABEL CHANGE OR A LABELLING PROCESS CHANGE AT COPAN? CEPHEID IS DOING A MORE INVESTIGATION, BUT WE WANTED TO GIVE YOU A HEADS UP. WE WILL UPDATE YOU WITH MORE DETAILS AS WE CONTINUE OUR INVESTIGATION. THANK YOU. CUSTOMER BELIEVED THAT THE LABEL LOCATED AT THE TOP OF THE TUBE PREVENT THE CAP NOT BEING ABLE TO TIGHTEN. THE LABEL IS TOUCHING THE LIQUID INSIDE, WHICH MAKES IT SPREAD DOWN THE TUBE AND IT'S LEAKING. THIS CUSTOMER RECEIVED THESE TWO BATCHES OF 900-0370. BATCH 221122800, 1500 SWABS. BATCH 221973300, 1000 SWABS. IF 900-0370 CANNOT SEAL TIGHT DURING TRANSPORTATION, THIS IS POTENTIAL CONTAMINATION ISSUES FOR OUR CUSTOMERS.". THE ISSUE WAS REFERRED TO TWO DIFFERENT LOT NUMBERS (221122800 AND 221973300). ON 10TH NOVEMBER 2023, COPAN ASKED THE DISTRIBUTOR TO PROVIDE SAMPLES, TO CONFIRM WHETHER OR NOT THE DEFECT WAS DETECTED DURING THE USE OF THE PRODUCT, AND TO SPECIFY IF THE PRODUCT WAS USED FOR DIAGNOSTIC PURPOSES. ON 13TH NOVEMBER 2023, THE DISTRIBUTOR CONFIRMED THAT THE DEFECT WAS DETECTED DURING THE USE OF THE PRODUCT AND WHILE PROCESSING PATIENTS SPECIMENS. ON 17TH NOVEMBER 2023, COPAN RECEIVED THE SAME COMPLAINT BY THE USER ITSELF, WHO CLAIMED 5 LOTS OF COPAN PRODUCT 900-0370 FOUND LEAKING (221122800, 221973300, 230397900, 230065900, AND 230627500). ON 20TH NOVEMBER 2023, COPAN ASKED DISTRIBUTOR TO VERIFY IF THE COMPLAINTS RECEIVED BY THE USER FOR LOT NUMBERS 221122800 AND 221973300 WERE THE SAME ONES ALREADY NOTIFIED BY THE DISTRIBUTOR ITSELF. ON THE SAME DATE, THE USER NOTIFIED TO COPAN ANOTHER COPAN PRODUCT FOUND LEAKING (COPAN PRODUCT CODE 220148, LOT 230627100). THIS PRODUCT AND PRODUCT CODE 900-0370 ARE IDENTICAL, AND THEY DIFFER ONLY FOR A LABELLING CUSTOMIZATION. ON 21ST NOVEMBER 2023, COPAN SENT TO DISTRIBUTOR AND TO USER A FORM USEFUL FOR THE INVESTIGATION OF THE DEFECT. ON 22ND NOVEMBER 2023, THE USER RETURNED THE FILLED FORM; IN THE FORM THE USER INDICATED THAT: - RECTAL SWABS WERE COLLECTED, CLOSED, PARAFILMED, PLACED IN INDIVIDUAL BIOHAZARD BAGS WITH ABSORBENT PAPER, AND SHIPPED AT AMBIENT TEMPERATURE VIA COURIER, FEDEX GROUND AND FEDEX AIR TRANSPORTATION, - SEVERAL PATIENTS HAD TO BE RECALLED TO PERFORM A NEW SAMPLE COLLECTION, SINCE THE TUBES HAVE BEEN FOUND LEAKING ONCE IN THE TESTING LABORATORY, AFTER TRANSPORTATION FROM THE COLLECTING SITE(S). ON 1ST DECEMBER 2023, COPAN AGAIN SOLICITED THE DISTRIBUTOR TO PROVIDE THE MISSING INFORMATION REGARDING INVOLVED USERS AND THEIR USAGE OF THE PRODUCT, EXACT NUMBER OF COMPLAINTS, AND EXACT INVOLVED LOT NUMBERS. NO ADDITIONAL INFORMATION WAS RECEIVED BY COPAN FROM THE DISTRIBUTOR TILL NOW.
ON 13TH DECEMBER 2023, DISTRIBUTOR CEPHEID, INC. SHARED WITH COPAN A SCAR DOCUMENT (B)(4), IN WHICH THEY REPORTED THE COMPLETE INFORMATION THEY HAD ABOUT THE LEAKING ISSUE INVOLVING COPAN'S PRODUCTS. ANALYSING THE SCAR'S CONTENT, COPAN ACKNOWLEDGED THAT: DISTRIBUTOR RECEIVED THE FIRST COMMUNICATION ABOUT LEAKY TUBES IN AUGUST 2023 FOR PRODUCT CODE 900-0370. AN ADDITIONAL LOT NUMBER (230535300) OF COPAN PRODUCT 900-0370 AND AN ADDITIONAL PRODUCT CODE (220109, LOT NUMBER 222088600) WERE CLAIMED AS LEAKING TO CEPHEID, IN OCTOBER 2023. OVERALL, A TOTAL OF 3 DIFFERENT USERS WERE THE SOURCES OF ALL THE COMPLAINTS: MARYLAND DEPARTMENT OF HEALTH, MINNESOTA DEPARTMENT OF HEALTH, AND ARROWHEAD REGIONAL MEDICAL CENTER. BOTH MARYLAND DEPARTMENT OF HEALTH AND MINNESOTA DEPARTMENT OF HEALTH CONFIRMED NO ADDITIONAL LIQUID WAS ADDED TO THE COLLECTION TUBES. NO OTHER DETAILS ABOUT THE PRODUCT USAGE WERE REPORTED. ON DATE 2ND JANUARY 2024, COPAN RECEIVED FROM FDA SIX (6) MEDWATCH REPORTS (REF. MW5149178, MW5149177, MW5149176, MW5149175, MW5149174, AND MW5149173), THAT WERE FORWARDED TO FDA FROM THE USER MARYLAND DEPARTMENT OF HEALTH (HEREAFTER, MDH). THE SIX (6) MEDWATCH REPORTS ARE TRACEABLE AND ADDRESSED TO THE COPAN MDR 3002444944-2023-00001.
UP TO DATE, NO ADDITIONAL PRODUCT CODES NOR LOT NUMBERS HAVE BEEN CLAIMED AS LEAKING.
UP TO DATE, NO ADDITIONAL PRODUCT CODES NOR LOT NUMBERS HAVE BEEN CLAIMED AS LEAKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 822293 | TRANSYSTEM¿ / CULTURESWAB¿ | TRANSYSTEM¿ / CULTURESWAB¿ | JSM | COPAN ITALIA SPA | 900-0370, 220148, 220109 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |