BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN

Additional Manufacturer Narrative

E1. INITIAL REPORTER FACILITY NAME: (B)(6). INVESTIGATION SUMMARY: BD RECEIVED 3 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION WAS OBSERVED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF (B)(6) 2025. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. 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 POOR BARRIER SEPARATION. 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. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.

Description of Event or Problem

IT WAS REPORTED WHILE USING BD VACUTAINER00489® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBITED POOR BARRIER SEPARATION AND RED BLOOD CELLS WERE MIGRATING INTO PERIPHERAL BLOOD MONONUCLEAR CELLS (PBMCS). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.