B.BRAUN

Additional Manufacturer Narrative

(B)(4). THE SAMPLE HAS BEEN RECEIVED AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION BECOME AVAILABLE.

Description of Event or Problem

AS REPORTED BY THE USER FACILITY: THE IV CONNECTOR BROKE APART AT THE ONE WAY VALVE, CAUSING BLOOD TO LEAK.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). ONE (1) UNOPENED SAMPLE WAS RETURNED FOR EVALUATION. FOUR (4) PICTURES WERE ALSO PROVIDED. THE RETURNED SAMPLE WAS OCCLUSION AND LEAKAGE TESTED, PER SPECIFICATION, WITH PASSING RESULTS. UPON VISUAL EXAMINATION OF THE RETURNED PICTURES, THE SETS WERE OBSERVED TO BE DETACHED AT THE SONIC WELD OF THE LOW PRESSURE BACK CHECK VALVES. THEREFORE, THE REPORTED DEFECT WAS CONFIRMED THROUGH THE PICTURE EVALUATION. THE DETACHING OF THE SETS CAN BE ATTRIBUTED TO A WEAK SONIC WELD OF THE LOW PRESSURE BACK CHECK VALVES. REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM (DSMS) DATABASE PERFORMED FOR THE REPORTED LOT NUMBER REVEALED NO ABNORMALITIES OR NON-CONFORMANCES DURING IN PROCESS OR FINAL PRODUCT INSPECTION. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NINE (9) ADDITIONAL USED SAMPLES WERE RETURNED FOR EVALUATION. THE NINE (9) ADDITIONAL SAMPLES WERE VISUALLY INSPECTED. FOUR (4) SAMPLES WERE NOTED TO BE DETACHED AT THE SONIC WELD OF THE LOW PRESSURE BACKCHECK VALVE AND FIVE (5) SAMPLES WERE NOTED TO BE DISCONNECTED AT THE BONDED JOINT BETWEEN THE TUBING AND THE SMALLBORE 3 LEG CONNECTOR. THEREFORE, THE REPORTED DEFECT WAS CONFIRMED THROUGH VISUAL EXAMINATION OF THE ADDITIONAL SAMPLES. ALTHOUGH OUR TRAINING PROCEDURES ENSURE THAT ALL OF OUR EMPLOYEES ARE PROPERLY TRAINED IN THEIR AREAS OF RESPONSIBILITY, AN OVERSIGHT ON THE PART OF THE OPERATOR CAN ATTRIBUTE TO AN INCIDENT OF DISCONNECTION AT THE BONDED JOINT. THE DETACHMENT OF THE SETS AT THE SONIC WELD IS DUE TO A WEAK SONIC WELD OF THE LOW PRESSURE BACKCHECK VALVES. REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM (DSMS) DATABASE PERFORMED FOR THE REPORTED LOT NUMBER REVEALED NO ABNORMALITIES OR NON-CONFORMANCES NOTED DURING IN PROCESS OR FINAL PRODUCT INSPECTION. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES.