PERIFIX®

Description of Event or Problem

AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: "WE HAD AN ISSUE WITH AN EPIDURAL CATHETER THAT BROKE OFF IN A PATIENT".

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.

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. NO SAMPLE WAS PROVIDED FOR EVALUATION. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. PER THE MANUFACTURERS INVESTIGATION, THIS DEFECT IS NOT LIKELY TO HAVE HAPPENED DURING THE MANUFACTURING PROCESS. IT IS BELIEVED TO HAPPEN DURING APPLICATION. B BRAUN KITS ARE PACKAGED ACCORDING TO BLUEPRINT SPECIFICATIONS WHILE INSPECTING FOR ANY DEFECTS OR DEVIATIONS FROM THE BLUEPRINT (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. 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.