BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

Additional Manufacturer Narrative

A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, ONE (1) OF TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9. RETURNED TO MANUFACTURER: YES H.3 DEVICE EVAL BY MANUFACTURER? YES D9. DEVICE AVAILABLE FOR EVAL: 12-JAN-2026 H.4. DEVICE MANUFACTURE DATE: 01-AUG-2025 INVESTIGATION SUMMARY: BD RECEIVED 6 SAMPLES FOR INVESTIGATION. THE 6 SAMPLES ALONG WITH 100 RETENTION SAMPLES WERE INSPECTED WITH NO ISSUES BEING IDENTIFIED. ADDITIONALLY, THE 6 RETURNED SAMPLES ALONG WITH 10 RETAINED SAMPLES WERE FUNCTIONALLY TESTED FOR DRAW VOLUME, AND ALL TUBES TESTED WITHIN SPECIFICATION LIMITS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: UNDERFILL. 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 THE IDENTIFICATION OF EMERGING TRENDS.

Description of Event or Problem

IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, ONE (1) OF TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.