BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN

Additional Manufacturer Narrative

B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 7 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODES FOR POOR BARRIER SEPARATION AND GEL SMEARING WAS OBSERVED. LOW YIELD CANNOT BE OBSERVED IN PHOTOS. ADDITIONALLY, 60 RETENTION SAMPLES FROM BD INVENTORY WERE VISUALLY INSPECTED WITH NO ISSUES OBSERVED. 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. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR POOR BARRIER SEPARATION AND GEL SMEARING BASED ON THE PHOTOS PROVIDED. BD IS UNABLE TO CONFIRM THIS COMPLAINT FOR LOW YIELD. OUR IFU (INSTRUCTIONS FOR USE) DOES NOT PROVIDE FOR ANY SPECIFIC YIELD CLAIMS. YIELDS DEPEND ON THE PATIENT, THE QUALITY OF THE SPECIMEN, AND THE METHOD USED FOR ISOLATION. 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 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¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN DURING A STUDY, AN UNSPECIFIED NUMBER OF TUBES EXHIBITED POOR BARRIER SEPARATION (INCLUDING EXCESSIVE RBC'S IN AND ON TOP OF THE GEL), GEL SMEARING (OFTEN CONTAINING RBC CONTAMINANTS), AND LOW YIELD AFTER PROCESSING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY : BD HAD NOT RECEIVED SAMPLES, BUT 7 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODES FOR POOR BARRIER SEPARATION AND GEL SMEARING WAS OBSERVED. LOW YIELD CANNOT BE OBSERVED IN PHOTOS. ADDITIONALLY, 60 RETENTION SAMPLES FROM BD INVENTORY WERE VISUALLY INSPECTED WITH NO ISSUES OBSERVED. 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. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR POOR BARRIER SEPARATION AND GEL SMEARING BASED ON THE PHOTOS PROVIDED. BD IS UNABLE TO CONFIRM THIS COMPLAINT FOR LOW YIELD. OUR IFU (INSTRUCTIONS FOR USE) DOES NOT PROVIDE FOR ANY SPECIFIC YIELD CLAIMS. YIELDS DEPEND ON THE PATIENT, THE QUALITY OF THE SPECIMEN, AND THE METHOD USED FOR ISOLATION. 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 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¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN DURING A STUDY, AN UNSPECIFIED NUMBER OF TUBES EXHIBITED POOR BARRIER SEPARATION(INCLUDING EXCESSIVE RBC'S IN AND ON TOP OF THE GEL), GEL SMEARING(OFTEN CONTAINING RBC CONTAMINANTS), AND LOW YIELD AFTER PROCESSING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.