PERIFIX®

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). 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, THE ROOT CAUSE OF THE REPORTED INCIDENT WAS UNABLE TO BE DETERMINED. 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.

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 VIA MEDWATCH NUMBER MW5169140: DURING PLACEMENT OF LUMBAR EPIDURAL CATHETER (DURING LABOR AND DELIVERY), THE CATHETER WOULD NOT THREAD. UPON REMOVAL OF CATHETER AND TUOHY NEEDLE TOGETHER CATHETER CAME OUT WITH APPROXIMATELY 1CM OF TIP SHEARED OFF. UNABLE TO FIND CATHETER TIP IN AREA SURROUNDING PATIENT. ANESTHESIA ALSO FOLLOWING UP WITH NEUROSURGERY TO DETERMINE RECOMMENDED FOLLOW UP PLAN. PATIENT IS G1P0 AT 40.2 WEEKS. PREGNANCY HAS BEEN COMPLICATED BY MATERNAL CELIAC, IRON DEFICIENCY, AND HSV WITH HSV PROPHYLAXIS STARTED AT 36 WEEKS. GBS NEGATIVE. SROM AT HOME; LABORED FOR SEVERAL HOURS BEFORE EPIDURAL WAS INSERTED. PATIENT ULTIMATELY HAD CESAREAN DELIVERY DUE TO FETAL DECELERATIONS.