BD VACUTAINER® CPT® NC: 1.0ML FICOLL¿: 2.0ML
Received Sep 23, 2025 · Event occurred Nov 17, 2024
Report 1917413-2025-01342 · MDR key 23127243
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton, Dickinson & Co. (broken Bow)Catalog number
362782
Lot number
3354414
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
REPORT 4 OF 4: IT WAS REPORTED WHILE USING BD VACUTAINER® CPT® NC: 1.0ML FICOLL¿: 2.0ML, 2 TUBES BROKE DURING CENTRIFUGATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, (B)(4) RETENTION SAMPLES FROM BOTH LOTS WERE INSPECTED AND NO ISSUES OR CRACKS WERE 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. A COMPLAINT HISTORY WAS PERFORMED AND NO TREND WAS OBSERVED. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE GLASS BREAKAGE DURING CENTRIFUGATION. 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.