PERIFIX®

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 & THE SURGEON FEEL THAT THE CATHETER WAS DEFECTIVE.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). ONE (1) UNOPENED SAMPLE, AND ONE (1) PHOTOGRAPH WERE PROVIDED FOR EVALUATION. VISUAL EVALUATION OF THE PHOTOGRAPH SHOWED THE BLISTER PACKAGING FOR THE REPORTED LOT NUMBER. THEREAFTER, THE RETURNED SAMPLE WAS VISUALLY INSPECTED AND PULL TESTED PER SPECIFICATION WITH PASSING RESULTS. BASED ON THE INVESTIGATION FINDING, THE SAMPLE WAS WITHIN INTERNAL SPECIFICATION; THEREFORE, THE REPORTED DEFECT WAS NOT REPLICATED OR CONFIRMED TO BE RELATED TO 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.