BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML

Additional Manufacturer Narrative

E1. INITIAL REPORTER ADDR1: (B)(6). E1.INITIAL REPORTER FACILITY NAME: (B)(6). 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

IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBITED POOR BARRIER SEPARATION AND LOW YIELD OF PERIPHERAL BLOOD MONONUCLEAR CELLS (PBMC'S) COMPARED TO THEIR HISTOPAQUE METHOD. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: BD RECEIVED THREE PHOTOS FOR INVESTIGATION. A VISUAL EXAMINATION OF THESE PHOTOS REVEALED POOR BARRIER SEPARATION; HOWEVER, THE LOW YIELD CANNOT BE OBSERVED IN PHOTOS. ADDITIONALLY, 49 RETAINED SAMPLES WERE VISUALLY INSPECTED WITH NO ISSUES IDENTIFIED. COMPLAINTS FOR SAMPLE QUALITY WERE NOT UNDER STATISTICAL CONTROL FOR THE MONTH OF MARCH 2025, ADDITIONAL TESTING WAS PERFORMED: NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES EXHIBITED PROPER FILL. BD WAS UNABLE TO DUPLICATE THE CUSTOMER¿S INDICATED FAILURE (POOR BARRIER SEPARATION) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. REPLICATES OF BOTH RETENTION AND CONTROL SAMPLES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL VISUAL OBSERVATIONS EVALUATED. ALL TUBES PERFORMED AS EXPECTED. THE IFU (INSTRUCTIONS FOR USE) FOR THIS PRODUCT DOES NOT SPECIFICALLY CLAIM A YIELD OF CELLS RATHER A PERCENT RECOVERY OF THE PATIENT'S WHOLE BLOOD CELL COUNT. 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 BASED ON THE PHOTOS PROVIDED. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: LOW YIELD. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECTS. 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 WHILE USING BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBITED POOR BARRIER SEPARATION AND LOW YIELD OF PERIPHERAL BLOOD MONONUCLEAR CELLS (PBMC'S) COMPARED TO THEIR HISTOPAQUE METHOD. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.