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Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A REPROCESSED EP CATHETER QUAD SUPREME COURNAND-2 AND THE INSIDE PACKAGE WAS NOT SEALED. THIS WAS DISCOVERED WHEN THEY WENT TO OPEN IT. THERE WAS NO DAMAGE, OR ANY OTHER ISSUE OBSERVED ON THE EXTERNAL PACKAGE OF THE DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

Additional Manufacturer Narrative

THE PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. 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 REF. NO: (B)(4).

Additional Manufacturer Narrative

IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A REPROCESSED EP CATHETER QUAD SUPREME COURNAND-2 AND THE INSIDE PACKAGE WAS NOT SEALED. THE RELATED PACKAGING OR LABELING WAS NOT RETURNED FOR ANALYSIS. A NON-STERILE REPROCESSED DAIG EP CATHETER WAS RECEIVED CONTAINED IN A DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS CONDUCTED, AND IT WAS OBSERVED THAT THE CATHETER WAS RETURNED WITH NO APPARENT DAMAGE. THE DEVICE WAS RECEIVED WITH A SERIAL NUMBER LABEL STILL ATTACHED. THE NOTED SERIAL NUMBER IS (B)(6). THIS SERIAL NUMBER IS LINKED TO LOT 2204339, WHICH HAD ONLY BEEN REPROCESSED ONE TIME. THE DESCRIBED EVENT COULD NOT BE CONFIRMED SINCE THE INVOLVED PACKAGING WAS NOT RETURNED OR RECEIVED FOR ANALYSIS. THERE IS NO EVIDENCE THAT ANY OF THE MATERIALS RECEIVED BY THE CUSTOMER HAD NOT BEEN SEALED OR THAT THE STERILITY HAD BEEN COMPROMISED. AS PART OF STERILMED'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ALL DEVICES, REPROCESSED UNDER LOT 2204339, UNDERWENT 100% INSPECTION AT DIFFERENT POINTS DURING THE MANUFACTURING PROCESS TO PREVENT ISSUES SUCH AS REPORTED FROM LEAVING THE FACILITY. THE DEVICE HISTORY RECORD WAS REVIEWED, AND THE DEVICE HAD PASSED ITS FINAL FINISHED GOODS INSPECTION AND QUALITY CHECK PRIOR TO BEING DISTRIBUTED TO THE CUSTOMER. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER 2204339, AND NO INTERNAL ACTIONS OR MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).