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: DESCRIPTION OF EVENT: DURING AN EPIDURAL PLACEMENT FOR A PATIENT IN LABOR, THE EPIDURAL CATHETER WAS FOUND TO HAVE SHEARED. THE CATHETER SEPARATED AT THE 5-CENTIMETER MARK. WE BELIEVE IT IS IMPORTANT TO NOTE THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. THE PRACTITIONER'S TECHNIQUE DURING THE PLACEMENT AND/OR REMOVAL ATTEMPT MAY NOT HAVE FOLLOWED ALL RECOMMENDED SAFETY PRECAUTIONS, WHICH COULD HAVE BEEN A CAUSATIVE FACTOR IN THE CATHETER SHEARING. PATIENT STATUS AND MANAGEMENT: THE PATIENT IS CURRENTLY STILL IN LABOR. THE DECISION REGARDING THE MANAGEMENT OF THE RETAINED CATHETER FRAGMENT (IN-SITU VS. SURGICAL REMOVAL) IS CURRENTLY UNDER CONSIDERATION BY THE CLINICAL TEAM, PENDING FURTHER EVALUATION. AN ULTRASOUND WAS PERFORMED, BUT THE FRAGMENT WAS NOT VISUALIZED. A CT SCAN HAS NOT YET BEEN PERFORMED BUT WILL OCCUR AS PART OF THE DIAGNOSTIC WORKUP AFTER PATIENT DELIVERY.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO SAMPLE AND/OR PHOTOGRAPHS WERE PROVIDED FOR EVALUATION; THEREFORE, THE REPORTED DEFECT COULD NOT BE CONFIRMED. FURTHER INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE. THE ACTUAL DEFECTIVE DEVICE IS A VALUABLE TOOL IN INVESTIGATING THE CAUSE OF THIS INCIDENT. IN THE FUTURE, IF THIS INCIDENT OCCURS AGAIN, PLEASE RETAIN THE SAMPLE SO THAT A COMPLETE INVESTIGATION CAN BE PERFORMED. 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 INSTRUCTION FOR USE (IFU) WHICH STATES, "PRECAUTION: ADVANCING THE CATHETER MORE THAN 5 CM PAST THE NEEDLE TIP MAY INCREASE THE LIKELIHOOD OF KINKING OR KNOTTING. CONSULT STANDARD TEXTBOOKS FOR SPECIFIC TECHNIQUES. CAUTION: FOR KIT CONTAINING CATHETERS, DO NOT WITHDRAW CATHETER THROUGH NEEDLE DUE TO POSSIBLE DANGER OF SHEARING OR KINKING." 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.