DESIGN OPTIONS®

Description of Event or Problem

AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: "DURING INSERTION OF AN EPIDURAL CATHETER ON A PATIENT, A PORTION OF THE PLASTIC COATING ON THE EPIDURAL CATHETER WIRE REMAINED IN THE PATIENT'S BACK WHILE REMOVING THE CATHETER. THE WIRE CAME OUT OF THE PATIENT'S BACK WITH A SECTION OF APPROXIMATELY 10 CM OF THE COATING MISSING." PULLED OUT CATHETER, NO SURGICAL REMOVAL, DISTAL END OF CATHETER. COULD BE IN THE PATIENT STILL.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). ONE USED CATHETER WITH PACKAGING LIDSTOCK AND TWO PHOTOS WERE PROVIDED FOR EVALUATION. VISUAL EVALUATION OF THE CATHETER SHOWED IT TO BE USED, FRAYED, AND KNOTTED. VISUAL EVALUATION OF ONE PHOTO SHOWED A USED, FRAYED, KNOTTED CATHETER AND THE OTHER CONFIRMED LIDSTOCK PACKAGING FROM THE REPORTED ITEM AND LOT. THE RETURNED SAMPLE AND PHOTOS WERE VISUALLY EVALUATED, AND NO DEFECT WAS ABLE TO BE CONFIRMED TO BE RELATED TO ANY MANUFACTURING PROCESS. 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 WILL BE REFERRED TO THE IFU WHICH STATES, "WARNINGS: · 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. CAUTION: DO NOT WITHDRAW CATHETER THROUGH NEEDLE BECAUSE OF THE POSSIBLE DANGER OF SHEARING OR KINKING. INSERT CATHETER TO DESIRED DEPTH. PRECAUTION: ADVANCING THE CATHETER MORE THAN 5 CM PAST THE NEEDLE TIP MAY INCREASE THE LIKELIHOOD OF KINKING OR KNOTTING. IF THE CATHETER BECOMES DIFFICULT TO WITHDRAW, CONSULT STANDARD TEXTBOOKS FOR SPECIFIC TECHNIQUES." 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.