PERIFIX®

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO SAMPLE AND/OR PHOTOGRAPHS WERE PROVIDED FOR EVALUATION; THEREFORE, THE REPORTED DEFECT COULD NOT BE CONFIRMED. FURTHER INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE. THE ACTUAL DEFECTIVE DEVICE IS A VALUABLE TOOL IN INVESTIGATING THE CAUSE OF THIS INCIDENT. IN THE FUTURE, IF THIS INCIDENT OCCURS AGAIN, PLEASE RETAIN THE SAMPLE SO THAT A COMPLETE INVESTIGATION CAN BE PERFORMED. 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. PER THE MANUFACTURERS INVESTIGATION THIS DEFECT IS NOT LIKELY TO HAVE HAPPENED DURING THE MANUFACTURING PROCESS. IT IS BELIEVED TO HAPPEN DURING APPLICATION. USER SHOULD REFER TO IFU WHICH STATES, "WARNING: DO NOT APPLY EXCESSIVE FORCE DURING NEEDLE ADVANCEMENT. DO NOT UTILIZE NEEDLE IF IT BENDS OR TIP BECOMES DAMAGED. NEEDLE WITH DAMAGED TIP INCREASES THE RISK OF INTRATHECAL OR INTRAVASCULAR PLACEMENT. IF RESISTANCE IS FELT DURING ADVANCEMENT OF THE NEEDLE, CAREFULLY CORRECT THE ORIENTATION OF THE NEEDLE BUT NEVER APPLY EXCESSIVE FORCE, FOLLOWING PUNCTURE AND VERIFICATION OF THE EPIDURAL SPACE, INTRODUCE CATHETER TIP THROUGH EPIDURAL NEEDLE USING THE THREAD ASSIST GUIDE." 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.

Description of Event or Problem

AS REPORTED VIA MEDWATCH NUMBER MW5176732: DESCRIBE EVENT OR PROBLEM: DURING AN EPIDURAL PLACEMENT- PRACTITIONER PULLED OUT THE TUOHY NEEDLE ATTEMPTING TO LEAVE THE CATHETER IN PLACE BUT NOTICED THAT THE CATHETER PULLED OUT WITH THE TUOHY. UPON EXAMINING THE CATHETER CLOSELY, IT WAS NOTICED THAT THE TIP WAS MISSING. THE PROCEDURE WAS ABORTED AT THAT POINT. MEASURED THE MISSING PORTION OF THE CATHETER WHICH I APPROXIMATE TO BE 4-4.5CM.

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.