EPIDURAL ANESTHESIA KIT

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO SAMPLE WAS PROVIDED; HOWEVER, THREE (3) PHOTOGRAPHS WERE SUBMITTED FOR EVALUATION. VISUAL EVALUATION OF THE PHOTOGRAPHS SHOWED A USED CATHETER, AND NO PACKAGING WITH THE VERY TIP TO BE CUT OFF. BASED ON VISUAL FINDINGS, THE PHOTOGRAPHS DID NOT PROVIDE SUFFICIENT EVIDENCE TO CONFIRM THE DEFECT TO BE RELATED TO THE MANUFACTURING PROCESS. IT SHOULD BE NOTED, THE EVENT SUMMARY STATES THE REPORTER WAS NOT SURE IF THIS WAS A USER ERROR. A THOROUGH INVESTIGATION COULD NOT BE PERFORMED WITHOUT A PROVIDED FINISHED GOOD ITEM, LOT NUMBER OR SAMPLE TO EVALUATE. IN ADDITION, THE PROVIDED PICTURES DO NOT OFFER THE DETAILS NECESSARY TO CONFIRM THE REPORTED DEFECT TO BE RELATED TO ANY MANUFACTURING PROCESS OR DETERMINE ANY ROOT CAUSE 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. 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 BY THE USER FACILITY: YESTERDAY MORNING WHEN I WAS PLACING AN EPIDURAL THERE WAS A COMPLICATION WHERE THE CATHETER BROKE. IT THREADED SMOOTHLY BUT I NOTICED BLOOD RETURN SHORTLY AFTERWARD. WHEN I WENT TO REMOVE IT THERE WAS NO RESISTANCE. I DIDN'T EVEN REALIZE IT BROKE INITIALLY. THE CT SHOWED IT ENTERING AT L2/3 AND TERMINATING IN THE EPIDURAL SPACE AT T12/L1. THE PATIENT IS NEUROLOGICALLY FINE BUT GOING OFF THE NEUROSURGERY CONSULT NOTE SHE WANTS IT REMOVED. I'M NOT SURE IF THIS IS USER-ERROR VS A MANUFACTURING DEFECT. THE BREAK IS SMOOTH AND DOESN'T APPEAR TO BE THINNED OUT BY TRACTION OR HAVE A ROUGH, SHEARED EDGE. THE CATHETER WAS REMOVED IN THE OR, SENT TO PATHOLOGY AND THEN TO RISK MANAGEMENT.

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.