PERIFIX®

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: ISSUE: THE PATIENT HAD THE EPIDURAL PLACED BY ANESTHESIA. LATER ON IN THE DAY SHE STARTED TO COMPLAIN OF SEVERE PAIN. WHEN THE ANESTHESIOLOGIST WENT TO EVALUATE HER AND TRACED THE LINE, HE SAW THAT THE TOP YELLOW ROUND PORTION OF THE CATHETER HAD BROKEN OFF AND THE ENTIRE BED WAS WET.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). RETAINED SAMPLE WAS EXAMINED; ALL COMPONENTS FROM THE KIT WERE VISUALLY INSPECTED AND NO DAMAGE OR DEFECTS WERE OBSERVED. THE CATHETER WAS ATTACHED TO THE CONNECTOR AND TESTED FOR LEAKAGE AND OCCLUSION PER SPECIFICATION WITH PASSING RESULTS. IN ADDITION, THE CATHETER WAS THEN PULL TESTED WITH PASSING RESULTS. THE RETAIN SAMPLE IS WITHIN SPECIFICATION. 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. NO SAMPLE WAS PROVIDED FOR EVALUATION. BASED ON THE DATA FROM THE INVESTIGATION WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. 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.