MULTI-AD®

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). TWO UNUSED SAMPLES IN SEALED PACKAGING WERE RETURNED FOR EVALUATION. THE SAMPLES WERE VISUALLY INSPECTED UPON ARRIVAL. ALL SAMPLES ARRIVED IN SEALED PACKAGING. AFTER REMOVING THEM FROM THE BLISTER PACKS, NO ISSUES OR PHYSICAL DEFECTS WERE OBSERVED. THE SETS WERE SUBSEQUENTLY LEAK TESTED, AND ALL RESULTS PASSED. NO LEAKAGE WAS DETECTED AT ANY BONDED JOINTS OR FILTERS. BASED ON THE SAMPLE EVALUATION, THE RESULTS MET INTERNAL SPECIFICATIONS; THEREFORE, NO PRODUCT DEVIATION WAS IDENTIFIED DURING THE INVESTIGATION. ALL AVAILABLE INFORMATION REGARDING THIS OCCURRENCE HAS BEEN FORWARDED TO THE APPROPRIATE MANUFACTURING BUSINESS UNIT IN ORDER TO HEIGHTEN AWARENESS. 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.

Description of Event or Problem

AS REPORTED BY THE USER FACILITY: THE HOSPITAL IS EXPERIENCING ISSUES WITH THE B BRAUN SECONDARY IV ADMINISTRATION SETS, WHERE THE CAPS ARE POPPING OFF DURING CHEMOTHERAPY ADMINISTRATION, RESULTING IN CHEMO SPILLS.