BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: BD RECEIVED ONE PHOTO FOR INVESTIGATION. THE EVALUATION OF THE PHOTO INDICATED THE PRESENCE OF POOR BARRIER SEPARATION. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF AUGUST 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. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: POOR BARRIER SEPARATION. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.

Description of Event or Problem

IT WAS REPORTED AFTER USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, THERE WAS POOR BARRIER SEPARATION SEEN IN THIRTY (30) TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

Description of Event or Problem

IT WAS REPORTED AFTER USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, THERE WAS POOR BARRIER SEPARATION SEEN IN THIRTY (30) TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

Additional Manufacturer Narrative

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