CATHETER EZ STEER BI-DIRECTIONAL CS DEFECTABLE CURVE TYPE: F-J 12 PIN AUTO ID

Additional Manufacturer Narrative

SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY STERILMED, INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, STERILMED, INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CATHETER EZ STEER BI-DIRECTIONAL CS DEFECTABLE CURVE TYPE: F-J 12 PIN AUTO ID AND AN ISSUE OCCURRED OF FOREIGN MATTER INSIDE THE PACKAGING. IT WAS REPORTED THAT THE REPROCESSED CATHETER (CATHETER EZ STEER BI-DIRECTIONAL CS DEFECTABLE CURVE TYPE: F-J 12 PIN AUTO ID) WAS DIRTY UPON OPENING THE PACKAGE. IT HAD BLOOD ON IT WHEN IT WAS OPENED. THE CATHETER WAS REPLACED AND THAT RESOLVED THE ISSUE. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE BLOOD WAS OBSERVED NEAR THE HANDLE. IT WAS INSIDE THE STERILE PACKAGE. IT WAS DESCRIBED AS DRIED BLOOD. THERE WAS NO PATIENT CONSEQUENCE AS IT WAS CAUGHT BEFORE IT WAS INTRODUCED INTO THE STERILE FIELD. THE EVENT WAS ASSESSED AS MDR REPORTABLE FOR FOREIGN MATTER INSIDE THE PACKAGING.

Additional Manufacturer Narrative

THE STERILMED PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 04-APR-2023. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

Additional Manufacturer Narrative

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CATHETER EZ STEER BI-DIRECTIONAL CS DEFECTABLE CURVE TYPE: F-J 12 PIN AUTO ID AND AN ISSUE OCCURRED OF FOREIGN MATTER INSIDE THE PACKAGING. IT WAS REPORTED THAT THE REPROCESSED CATHETER (CATHETER EZ STEER BI-DIRECTIONAL CS DEFECTABLE CURVE TYPE: F-J 12 PIN AUTO ID) WAS DIRTY UPON OPENING THE PACKAGE. IT HAD BLOOD ON IT WHEN IT WAS OPENED. THE CATHETER WAS REPLACED AND THAT RESOLVED THE ISSUE. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE BLOOD WAS OBSERVED NEAR THE HANDLE. IT WAS INSIDE THE STERILE PACKAGE. IT WAS DESCRIBED AS DRIED BLOOD. THERE WAS NO PATIENT CONSEQUENCE AS IT WAS CAUGHT BEFORE IT WAS INTRODUCED INTO THE STERILE FIELD. THE DEVICE EVALUATION WAS COMPLETED ON 11-APR-2023. THE DEVICE WAS RETURNED TO STERILMED FOR FURTHER INVESTIGATION. A NON-STERILE REPROCESSED EZ STEER BI-DIRECTIONAL CS CATHETER WAS RECEIVED CONTAINED IN THE DECONTAMINATION BAG. UPON RECEIPT OF THE CATHETER, VISUAL INSPECTION WAS PERFORMED, AND IT REVEALED THAT THE CATHETER WAS RETURNED WITH NO APPARENT DAMAGE. THE TAG ID ATTACHED TO THE CATHETER INDICATED THAT IT HAD BEEN REPROCESSED ONE (1) TIME. THE ISSUE DOCUMENTED THAT THE CATHETER HAD BLOOD RESIDUES NEAR THE HANDLE COULD NOT BE CONFIRMED SINCE THE PRODUCT WAS RECEIVED WITHOUT ANY FOREIGN MATTER. NO ADDITIONAL EVIDENCE WAS PROVIDED SHOWING THE ALLEGED ISSUE. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THE LOT 2182815 REVEALED THAT THERE WERE NO INTERNAL ACTIONS RELATED TO DEVICE MANUFACTURE OR INSPECTION. AS PART OF STERILMED¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. DEVICES UNDERGO 100% VISUAL INSPECTION TO DETECT THE PRESENCE OF CONTAMINANTS DURING THE REPROCESSING CYCLE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).