PERIFIX®

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). TWENTY-SIX (26) UNOPENED SAMPLES AND ONE (1) PHOTOGRAPH WERE PROVIDED FOR EVALUATION. VISUAL EVALUATION OF THE PHOTOGRAPH SHOWED BLISTER PACKAGING FOR THE REPORTED LOT NUMBER. THEREAFTER, THE RETURNED SAMPLES WERE VISUALLY INSPECTED AND PULL TESTED PER SPECIFICATION WITH PASSING RESULTS. BASED ON THE INVESTIGATION FINDINGS, THE SAMPLES MET INTERNAL SPECIFICATION; THEREFORE, THE REPORTED DEFECT COULD NOT BE CONFIRMED. THE ROOT CAUSE OF THE REPORTED DEFECT WAS NOT ABLE TO BE DETERMINED AT THE TIME OF TESTING. THE MOST LIKELY ROOT CAUSE IS DUE TO FURTHER PROCESSING/HANDLING DURING CLINICAL USE. B BRAUN KITS ARE PACKAGED ACCORDING TO BLUEPRINT SPECIFICATIONS WHILE INSPECTING FOR ANY DEFECTS OR DEVIATIONS FROM DRAWING (E.G. EMBEDDED PARTICLES, DIRT, MISSING OR INCORRECTLY ASSEMBLED PARTS, ETC.). IN ADDITION, THERE ARE INCOMING, IN PROCESS AND FINAL FUNCTIONAL INSPECTIONS PERFORMED DURING THE MANUFACTURING OF COMPONENTS AND FINISHED GOOD ITEMS. PER THE MANUFACTURERS INVESTIGATION THIS DEFECT IS NOT LIKELY TO HAVE HAPPENED DURING THE MANUFACTURING PROCESS. A REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM (DSMS) DATABASE WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NON-CONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

Description of Event or Problem

AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: ON MONDAY, (B)(6) 2025 A PATIENT HAD AN EPIDURAL CATHETER PLACED INTRAOPERATIVELY FOR PAIN CONTROL FOLLOWING A MULTI-LEVEL POSTERIOR SPINAL FUSION. ON POD 2 WHEN THE PA WAS REVVING THE CATHETER, IT SEPARATED, AND A SECTION OF THE CATHETER REMAINED IN THE PATIENT'S BACK. THE PATIENT RETURNED TO THE OR LATER THAT AFTERNOON FOR AN EXPLORATION OF THE POST-OP LUMBAR WOUND AND REMOVAL OF THE RETAINED EPIDURAL CATHETER. THE SEGMENT WAS SUCCESSFULLY REMOVED. BOTH THE ANESTHESIOLOGIST AND THE SURGEON FEEL THAT THE CATHETER WAS DEFECTIVE.