PERIFIX®

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). ONE USED SINGLE CATHETER WITH LID STOCK PACKAGING IDENTIFYING THE REPORTED LOT NUMBER AND SEVERAL PHOTOGRAPHS WERE PROVIDED FOR INVESTIGATION. UPON EVALUATION OF THE SAMPLES AND PHOTOGRAPHS, A USED CATHETER WAS OBSERVED TO BE DAMAGED, KINKED/ TWISTED, WITH THE COIL STRETCHED OUT AND THE TIP SHEARED OFF. THE CATHETER HAS BEEN OPENED AND SEVERELY DAMAGED DURING USE, THEREFORE THE REPORTED CONCERN WAS UNABLE TO BE CONFIRMED TO BE THE RESULT OF ANY MANUFACTURING PROCESS. PER THE MANUFACTURER'S INVESTIGATION, THIS DEFECT WAS 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 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 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 THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: FX SPRINGWOUND CATHETER FELL APART WHILE BEING REMOVED FORM A PATIENT REQUIRING SURGERY TO REMOVE ANY LEFT OVER PIECES OF THE CATHETER LEFT INSIDE PATIENT.