PERIFIX®

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). ONE UNOPENED AND ONE USED SAMPLE WAS PROVIDED FOR EVALUATION. UPON VISUAL INSPECTION OF THE RETURNED SAMPLE, THE USED CATHETER SHOWED TO BE DAMAGED AND SHEARED. THE UNUSED CATHETER FROM THE UNOPENED KIT WAS PULL TESTED AND THE COIL WAS MEASURED WITH PASSING RESULTS. PER THE MANUFACTURERS INVESTIGATION, THIS DEFECT IS NOT LIKELY TO HAVE HAPPENED DURING THE MANUFACTURING PROCESS. IT IS BELIEVED TO HAVE HAPPENED DURING APPLICATION. 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 USER FACILITY: BRIEF INQUIRY DESCRIPTION: FX CATHETER REMOVAL INCOMPLETE. DETAILED INQUIRY DESCRIPTION: A PORTION OF FX CATHETER REMAINED INSIDE PATIENT. DESCRIPTION OF THE PATIENT EVENT: UPON ATTEMPTED REMOVAL OF FX CATHETER, A PORTION REMAINED INSIDE PATIENT LIVE CALL RECEIVED ON (B)(6) 2024: ON (B)(6) 2024 PATIENT WAS IN LABOR AND DELIVERY. STAFF ADMINISTERED AN EPIDURAL AND NOT PROBLEMS PUTTING THE CATHETER IN BUT ONCE THEY WENT TO REMOVE IT PART OF THE DEVICE STAYED IN THE PATIENT AS IT HAD BROKEN OFF. THE DEVICE WAS NOTED TO BE FRAYED AND THREADED OUT. THE PATIENT WAS ABLE TO DELIVER AND THERE WAS NO IMPACT TO THE CHILDBIRTH. PATIENT BEING TRANSFERRED TO A NEUROSURGEON TO SEE IF HE CAN REMOVE THE DEVICE (MAY HAVE BEEN TRANSFERRED LAST NIGHT OR MAY GO TODAY). IT IS UNKNOWN IF SHE WILL BE NUMBER LOCALLY OR IF SHE HAS TO GO UNDER ANESTHESIA. THE REPORTER DOES NOT HAVE ANY IDEA CLINICALLY HOW THIS WILL BE PERFORMED. REPORTER WILL PROVIDE ADDITIONAL INFORMATION REGARDING THE ATTEMPT TO REMOVE AND THE PATIENT STATUS AFTER THE PROCEDURE.