BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

Description of Event or Problem

IT WAS REPORTED DURING USE OF BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBITED POOR VIABILITY OF PERIPHERAL BLOOD MONONUCLEAR CELLS (PBMC'S). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

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.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: BD HAD NOT RECEIVED ANY SAMPLES FOR INVESTIGATION. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN. FURTHER TESTING COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: ERRONEOUS RESULTS (POOR VIABILITY). 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.

Description of Event or Problem

IT WAS REPORTED DURING USE OF BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBITED POOR VIABILITY OF PERIPHERAL BLOOD MONONUCLEAR CELLS (PBMC'S). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.