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: CUSTOMER VISIT TO HUNTERDON ON (B)(6) 2025 WHERE THE PROVIDERS REPORTED ADVERSE EVENTS WHERE THE CATHETER IN THE TRAY WAS SHEARED BY THE TUOHY NEEDLE DURING REMOVAL OF THE NEEDLE AT EPIDURAL INSERTION TIME. AFTER THE TUOHY WAS REMOVED AND THE CATHETER WAS IN PLACE, THEY NOTICED THE CATHETER WAS DAMAGED UPON FLUSHING. A NEW PROCEDURE WAS PERFORMED TO REPLACE THE CATHETER. UPON INVESTIGATION, THESE ARE UNCOMPLICATED INSERTIONS, THE PATIENTS ANATOMY WAS CONDUCIVE TO EASY INSERTION PROCEDURES, THE TUOHY WAS INSERTED WITHOUT ISSUES, THEN THE CATHETER IS THREADED INTO THE NEEDLE WITHOUT PROBLEMS. THERE IS NO CATHETER OR TUOHY MANIPULATION BACK AND FORTH DURING THE INSERTION. IFU IS FOLLOWED. THESE ARE DIFFERENT EXPERIENCED PROVIDERS. "WHEN COMES TIME TO REMOVE THE TUOHY, IT LOOKS LIKE THE TUOHY NEEDLE SHEARS THE CATHETER ON ITS WAY OUT".

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). 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. THE RETAIN CATHETER WAS TESTED AND PASSED PER SPECIFICATION. PER THE MANUFACTURERS INVESTIGATION, THE REPORTED INCIDENT WAS NOT LIKELY TO HAVE HAPPENED DURING THE MANUFACTURING PROCESS. IT IS BELIEVED TO HAVE HAPPENED DURING APPLICATION. NO SAMPLE WAS PROVIDED FOR EVALUATION. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. 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.