DESIGN OPTIONS®

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: WRITING TO REPORT ANOTHER EVENT OF EPIDURAL CATHETER SHEARING. TODAY ON OB, PLACED A ROUTINE EPIDURAL CATHETER ON 1 ATTEMPT. AFTER THREADING THE CATHETER, SHE ATTEMPTED TO REMOVE THE TUOHY VIA PUSH/PULL AND MET RESISTANCE. SHE THEN REMOVED THE ENTIRE TOUHY FROM THE PATIENT'S BACK TO FIND THE CATHETER SHEARED AS YOU SEE BELOW. LUCKILY, AS SHE CONTINUED TO GENTLY PULL, THE TIP OF THE CATHETER CAME OUT, BUT YOU CAN SEE HOW THIN THE REMNANTS ARE. EASILY COULD HAVE BROKEN OFF AND BEEN LODGED IN THE PATIENT'S BACK AND A MAJOR ISSUE.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). TWO PHOTOGRAPHS WERE PROVIDED FOR EVALUATION. UPON VISUAL INSPECTION OF THE PICTURES, IT SHOWED LIDSTOCK PACKAGING AND A USED CATHETER THAT WAS SHEARED A FEW INCHES FROM THE TIP WITH THE COILED STRETCHED AND KINKED. THE NEEDLE STILL HAD THE PARTIAL CATHETER THREADED THROUGH IT. BASED ON THE DATA FROM THE INVESTIGATION, THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED TO BE RULED OUT TO BE THE RESULT OF USER APPLICATION. PER THE MANUFACTURERS INVESTIGATION THIS DEFECT IS NOT LIKELY TO HAVE HAPPENED DURING THE MANUFACTURING PROCESS. IT IS BELIEVED TO HAPPEN DURING APPLICATION. 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.