EPIDURAL ANESTHESIA KIT

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: DESCRIPTION OF EVENT: CLINICIAN WAS INSERTING THE EPIDURAL, NORMAL LOR, WENT TO THREAD CATHETER AND COULD NOT ADVANCE, PULLED BACK CATHETER SLIGHTLY AND GOT RESISTANCE SO PULLED OUT EVERYTHING ALL TOGETHER AT THAT POINT. NOTICED END OF CATHETER WAS EXTREMELY STRETCHED OUT. DROPPED ANOTHER CATHETER ON THE FIELD. RE-SELECTED THE TUOHY, PLACED ANOTHER EPIDURAL ONE SPACE UP. AFTER PROCEDURE LOOKED AT THE FAILED CATHETER, NOTICED THE BLUE TIP WAS MISSING FROM THE END. DID IMAGING AND DID NOT SEE ANYTHING IN PT. PATIENT DOES NOT HAVE ANY ADVERSE REACTIONS.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO SAMPLE WAS PROVIDED FOR EVALUATION. BASED ON THE DATA FROM THE INVESTIGATION, THE ROOT CAUSE OF THE REPORTED INCIDENT WAS UNABLE TO BE DETERMINED. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. NO ROOT CAUSE IS ABLE TO BE DETERMINED AT THIS TIME. 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. 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.