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

Additional Manufacturer Narrative

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¿: 2.0 ML, 5 TUBES BROKEN DURING CENTRIFUGATION RESULTING IN SAMPLE LOSS. THERE WAS NO OTHER 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. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: GLASS BREAKAGE DURING CENTRIFUGATION. 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 WHILE USING BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML, 5 TUBES BROKEN DURING CENTRIFUGATION RESULTING IN SAMPLE LOSS. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.