BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

Additional Manufacturer Narrative

D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE ,1 PATIENT SAMPLE EXHIBITED POOR BARRIER SEPARATION. 2 SAMPLES WERE COLLECTED ON THE PATIENT DURING THE SAME COLLECTION, AND AFTER PROCESSING ONLY ONE SAMPLE EXHIBITED POOR BARRIER SEPARATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: BD RECEIVED ONE PHOTO FOR INVESTIGATION. THE VISUAL EVALUATION OF THE PHOTO CONFIRMS POOR BARRIER SEPARATION. THE RETENTIONS COULD NOT BE INSPECTED AS THE LOT NUMBER IS UNKNOWN. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF FEBRUARY 2025. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN. 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

REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE 1, PATIENT SAMPLE EXHIBITED POOR BARRIER SEPARATION. 2 SAMPLES WERE COLLECTED ON THE PATIENT DURING THE SAME COLLECTION, AND AFTER PROCESSING ONLY ONE SAMPLE EXHIBITED POOR BARRIER SEPARATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.