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

Additional Manufacturer Narrative

B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 DURING USE OF BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML, AN UNSPECIFIED NUMBER OF SAMPLES HAVE LOW YIELD OF PERIPHERAL BLOOD MONONUCLEAR CELLS (PBMC')S. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY : BD HAD NOT RECEIVED ANY SAMPLES OR PHOTOS FOR INVESTIGATION. A TOTAL OF 60 RETAINED SAMPLES WERE VISUALLY INSPECTED, WITH NO ISSUES BEING IDENTIFIED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. 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. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: LOW YIELD. 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¿ NH: ~130 IU FICOLL¿: 2.0ML, AN UNSPECIFIED NUMBER OF SAMPLES HAVE LOW YIELD OF PERIPHERAL BLOOD MONONUCLEAR CELLS (PBMC')S. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.