PERIFIX®

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). ONE (1) USED CATHETER AND SPINAL NEEDLE WITH LIDSTOCK PACKAGING WERE PROVIDED FOR EVALUATION. VISUAL EVALUATION OF THE USED CONTAMINATED CATHETER SHOWED IT TO BE SHEARED, DAMAGED, AND THE COIL TO BE EXTREMELY STRETCHED OUT. SINCE THE CATHETER WAS NOT IN THAT CONDITION UPON OPENING THE KIT, THE DAMAGE AND SHEARING IS NOT CONFIRMED TO BE RELATED TO THE 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 SHOULD REFER TO IFU WHICH STATES: "WARNINGS: DO NOT APPLY EXCESSIVE FORCE DURING NEEDLE ADVANCEMENT. DO NOT UTILIZE NEEDLE IF TIP BECOMES DAMAGED. NEEDLE WITH DAMAGED TIP INCREASED 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." 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.

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. 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. 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.

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: BRIEF INQUIRY DESCRIPTION: EPIDURAL CATHETER FAILED/STRIPPED AND LODGED IN PATIENT. DETAILED INQUIRY DESCRIPTION CRNA WAS THREADING THE CATHETER INTO THE SHEATH WHEN RESISTANCE WAS MET IN THE SPACE BETWEEN L2 AND L3 VERTEBRAE. UPON RETRACTION OF THE CATHETER, IT WAS NOTICEABLY "STUCK" IN THE SPACE. AFTER RETRACTION OF SHEATH AND CATHETER IT WAS NOTED THAT A 3.5CM PIECE OF SHEATH WAS LOGGED BETWEEN THE L2 AND L3 VERTEBRAE. ADDITIONALLY, THERE ARE NOTABLE SPACES ON THE SHEATH WHERE IT APPEARS STRETCHED. THE PATIENT RECEIVED A CT AND XRAY IMAGING FROM THE IN-HOUSE TEAM THERE WAS NO CONCERN OF FURTHER ISSUE. THE PATIENT WILL BE SEEN IN OUTPATIENT SETTING TO HAVE THE 3.5CM PIECE OF SHEATH REMOVED.