PERIFIX®

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). ONE (1) USED CATHETER AND CONNECTOR WITH A PHOTOGRAPH OF THE LIDSTOCK PACKAGING WERE PROVIDED FOR EVALUATION. THE RETURNED SAMPLE WAS TESTED FOR OCCLUSION PER SPECIFICATION WITH PASSING RESULTS. HOWEVER, VISUAL EVALUATION OF THE CATHETER SHOWED THE TIP TO BE COMPLETELY SHEARED OFF. ALTHOUGH BREAKAGE OF THE CATHETER TIP WAS OBSERVED, THE DEFECT WAS NOT CONFIRMED TO BE DUE TO THE MANUFACTURING PROCESS. PER THE MANUFACTURERS INVESTIGATION THIS DEFECT IS NOT LIKELY TO HAVE HAPPENED DURING THE MANUFACTURING PROCESS. IT IS BELIEVED TO HAPPEN DURING CLINICAL APPLICATION. THIS PRODUCT IS RECOMMENDED TO BE USED IN ACCORDANCE TOW THE INSTRUCTIONS FOR USE (IFU) FOR KIT AND COMPONENT WARNINGS AND CAUTIONS. 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. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) 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: REASON OF COMPLAINT: THE EPIDURAL CATHETER INFUSION PUMP INITIALLY RAN WITHOUT ISSUE, THOUGH OFF SINCE OCCLUSION ALARM AND RESISTANCE TO FLUSH NOTED AT 1527. PER DISCUSSION WITH PROCEDURAL TEAM, UNEVENTFUL PLACEMENT, LOR-2 CM, CATHETER EASILY ADVANCED WITHOUT RESISTANCE, SECURED - 10CM W/ GLUE AND INFUSION INITIALLY RAN WITHOUT ISSUES. PATIENT REPOSITIONED ON THE LEFT SIDE AND CATHETER ASSESSED. NO APPARENT KINKING, ASPIRATION NEGATIVE SIGNIFICANT RESISTANCE TO FLUSH ATTEMPT. CATHETER DRESSING TAKEN DOWN FOR FARTHER EVALUATION. INSERTION SITE, SURROUNDING SKIN, AND CATHETER ALL APPEARING UNREMARKABLE. CATHETER STILL INTACT AND SECURE WITH SKIN GLUE AT 12 CM EASILY WITHDRAWN TO 10 CM, CONTINUED RESISTANCE TO FLUSH ATTEMPT AT INSERTION SITE AND FRACTURED TIP NOTED AT SKIN. REMAINDER COMPONENT OF CATHETER IS NOT PALPABLE ON EXAM AND INSERTION SITE APPEARS UNREMARKABLE. ESTIMATED LENGTH OF RETAINED CATHETER IS 8 CM.