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

IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML AN UNSPECIFIED NUMBER OF TUBES SHOW CLUMPING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

Description of Event or Problem

IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® CPT¿ NH: 130 IU FICOLL¿: 2.0ML AN UNSPECIFIED NUMBER OF TUBES SHOW CLUMPING. 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: (B)(6) 2025. INVESTIGATION SUMMARY: BD RECEIVED 60 SAMPLES FOR INVESTIGATION. THESE RETURNED SAMPLES ALONG WITH 60 RETAINED SAMPLES WERE VISUALLY INSPECTED, AND NO ISSUES WERE 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: ADDITIVE ABNORMALITY. 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.