BD VACUTAINER® CPT® NC: 1.0ML FICOLL¿: 2.0ML

Additional Manufacturer Narrative

THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 05-DEC-2024. INVESTIGATION SUMMARY: BD RECEIVED TWELVE (12) SAMPLES AND THREE (3) PHOTOS FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR BROKEN TUBE WAS 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. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE OF BROKEN TUBE. 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

IT WAS REPORTED DURING USE OF BD VACUTAINER® CPT® NC: 1.0ML FICOLL¿: 2.0 ML, ONE TUBE BROKE IN THE CENTRIFUGE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

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 DURING USE OF BD VACUTAINER® CPT® NC: 1.0ML FICOLL¿: 2.0ML, ONE TUBE BROKE IN THE CENTRIFUGE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.