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

Additional Manufacturer Narrative

E1. INITIAL REPORTER PHONE #: (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

REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML, 1 TUBE BROKE IN THE CENTRIFUGE DURING PROCESSING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 12-SEP-2025. INVESTIGATION SUMMARY: BD RECEIVED (B)(4) SAMPLES FOR INVESTIGATION. THE SAMPLES WERE ALL VISUALLY INSPECTED WITH NO ISSUES BEING IDENTIFIED. NO FURTHER TESTING WITH THE CENTRIFUGATION PROCESS IS INDICATED AT THIS TIME BASED ON THE LOW DEFECT RATE. ADDITIONALLY, (B)(4) RETAINED SAMPLES WERE INSPECTED, WITH NO ISSUES 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 LOT 4346569 FOR THE INDICATED FAILURE MODES: IMPROPER ASSEMBLY AND GLASS BREAKAGE DURING CENTRIFUGATION. 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

REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML, 1 TUBE BROKE IN THE CENTRIFUGE DURING PROCESSING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.