TERUMO SAMPLING SITE COUPLER

Additional Manufacturer Narrative

INVESTIGATION: INVESTIGATION RESULT OF MANUFACTURING PROCESSTHE PRODUCT CONCERNED IS MANUFACTURED ACCORDING TO THE FOLLOWING PROCESS FLOW. [TC*MP1 ASSEMBLING/STERILIZATION FLOW]1) ATTACH THE PROTECTOR, THE RUBBER CAP, AND THE CAP TO THE SPIKE. (ASSEMBLING)2) VISUALLY INSPECT THE ASSEMBLY.3) PACK THE ASSEMBLY INTO THE INDIVIDUAL PACKAGE, AND SEAL THE PACKAGE WITH THE PACKAGE SEALING MACHINE.4) PACK 50 SEALED INDIVIDUAL PACKAGE INTO ONE UNIT BOX.5) WEIGH THE UNIT BOX TO VERIFY THE QUANTITY INSIDE THE BOX.6) PACK 20 UNIT BOXES INTO ONE SHIPPING CARTON BOX.7) LOAD THE SHIPPING CARTON BOXED ON THE STERILIZATION PALLET AND CONDUCT ETO STERILIZATION. THE INVESTIGATION WAS CONDUCTED BASED ON THE REPORTED INFORMATION, AND NO EQUIPMENT MALFUNCTIONS OR DEVIATIONS WERE OBSERVED IN THE ASSEMBLING, PACKAGING, OR STERILIZATION PROCESSES. INVESTIGATION OF OCCURRENCES OF SIMILAR ISSUESIT WAS CONFIRMED THAT NO SIMILAR ISSUES HAD BEEN REPORTED FROM OTHER MEDICAL FACILITIES AS OF FEBRUARY 26, 2026. REGARDING THE PRODUCT CONCERNED, THERE HAVE BEEN NO RECALLS ASSOCIATED WITH POSITIVE STERILITY. ROOT CAUSE: BASED ON THE INVESTIGATIONS ABOVE, NO ABNORMALITIES WERE IDENTIFIED IN THE ASSEMBLING, PACKAGING, OR STERILIZATION PROCESSES, AND NO SIMILAR ISSUES HAVE BEEN REPORTED BY OTHER FACILITIES. THEREFORE, WE WERE UNABLE TO IDENTIFY THE SPECIFIC CAUSE OF THE OCCURRENCE OF THIS ISSUE. AS STATED IN THE IFU, THIS PRODUCT SHOULD BE USED IMMEDIATELY AFTER OPENING THE PACKAGE, AND SHOULD NOT BE REUSED, RE-STERILIZED, OR REPROCESSED.

Description of Event or Problem

THE CUSTOMER REPORTED POSITIVE STERILITY IN A WHOLE BLOOD UNIT. THE ORGANISM IDENTIFIED BY SEQUENCING USING BIOMERIEUX BACT ALERT 3D WAS PAENIBACILLUS DAKARENSIS. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

Additional Manufacturer Narrative

THIS REPORT IS BEING FILED TO PROVIDE CORRECTED INFORMATION IN D.1 AND D.2B. INVESTIGATION: INVESTIGATION RESULT OF MANUFACTURING PROCESS THE PRODUCT CONCERNED IS MANUFACTURED ACCORDING TO THE FOLLOWING PROCESS FLOW. [TC*MP1 ASSEMBLING/STERILIZATION FLOW]1) ATTACH THE PROTECTOR, THE RUBBER CAP, AND THE CAP TO THE SPIKE. (ASSEMBLING)2) VISUALLY INSPECT THE ASSEMBLY.3) PACK THE ASSEMBLY INTO THE INDIVIDUAL PACKAGE, AND SEAL THE PACKAGE WITH THE PACKAGE SEALING MACHINE.4) PACK (B)(4) SEALED INDIVIDUAL PACKAGE INTO ONE UNIT BOX.5) WEIGH THE UNIT BOX TO VERIFY THE QUANTITY INSIDE THE BOX.6) PACK (B)(4) UNIT BOXES INTO ONE SHIPPING CARTON BOX.7) LOAD THE SHIPPING CARTON BOXED ON THE STERILIZATION PALLET AND CONDUCT ETO STERILIZATION. THE INVESTIGATION WAS CONDUCTED BASED ON THE REPORTED INFORMATION, AND NO EQUIPMENT MALFUNCTIONS OR DEVIATIONS WERE OBSERVED IN THE ASSEMBLING, PACKAGING, OR STERILIZATION PROCESSES. INVESTIGATION OF OCCURRENCES OF SIMILAR ISSUE SIT WAS CONFIRMED THAT NO SIMILAR ISSUES HAD BEEN REPORTED FROM OTHER MEDICAL FACILITIES AS OF FEBRUARY 26, 2026. REGARDING THE PRODUCT CONCERNED, THERE HAVE BEEN NO RECALLS ASSOCIATED WITH POSITIVE STERILITY. ROOT CAUSE: BASED ON THE INVESTIGATIONS ABOVE, NO ABNORMALITIES WERE IDENTIFIED IN THE ASSEMBLING, PACKAGING, OR STERILIZATION PROCESSES, AND NO SIMILAR ISSUES HAVE BEEN REPORTED BY OTHER FACILITIES. THEREFORE, WE WERE UNABLE TO IDENTIFY THE SPECIFIC CAUSE OF THE OCCURRENCE OF THIS ISSUE. AS STATED IN THE IFU, THIS PRODUCT SHOULD BE USED IMMEDIATELY AFTER OPENING THE PACKAGE, AND SHOULD NOT BE REUSED, RE-STERILIZED, OR REPROCESSED.

Description of Event or Problem

THE CUSTOMER REPORTED POSITIVE STERILITY IN A WHOLE BLOOD UNIT. THE ORGANISM IDENTIFIED BY SEQUENCING USING BIOMERIEUX BACT ALERT 3D WAS PAENIBACILLUS DAKARENSIS. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.