BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: BD JAPAN RECEIVED 1 SAMPLE AND 6 PHOTOS WERE PROVIDED FOR INVESTIGATION. VISUAL EXAMINATION OF BOTH REVEALED FOREIGN MATTER (FM) ON THE INSIDE OF THE TUBE. THERE IS A BROWN PARTICLE INSIDE THE TUBE. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE FM. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

Description of Event or Problem

IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, FOREIGN MATTER (FM) WAS OBSERVED INSIDE ONE TUBE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.