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

Additional Manufacturer Narrative

THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 44 RETENTION SAMPLES FROM BD INVENTORY WERE VISUALLY INSPECTED WITH NO ISSUES OBSERVED. 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. A COMPLAINT HISTORY WAS PERFORMED AND ONE OTHER COMPLAINT HAS BEEN RECEIVED ON THIS LOT NUMBER FOR THE REPORTED DEFECT(FROM THE SAME CUSTOMER). THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE REPORTED DEFECT, LOW YIELD. 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.

Description of Event or Problem

REPORT 1 OF 4. IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ NH: ~130 U FICOLL¿: 2.0ML IN A STUDY COMPARING CPT TUBES TO LEUCOSEP TUBES, CELL YIELDS WERE LOWER THAN EXPECTED IN A DONOR SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.