BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE
Received Jun 18, 2026 · Event occurred May 23, 2026
Report 1917413-2026-00548 · MDR key 25548187
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton Dickinson & Co (franklin Lakes)Catalog number
362761
Lot number
5287685
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, 1 TUBE BROKE DURING CENTRIFUGATION AND SAMPLE LEAKED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Additional Manufacturer Narrative
E.1: INITIAL REPORTER FACILITY NAME: (B)(6). BD RECEIVED 2 PHOTOS FOR INVESTIGATION. THE PHOTOS SHOW THAT THE GLASS TUBE IS BROKEN. 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 BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: GLASS BREAKAGE. 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 THE IDENTIFICATION OF EMERGING TRENDS.