BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE
Received May 11, 2026 · Event occurred Apr 13, 2026
Report 1917413-2026-00412 · MDR key 25141762
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton Dickinson & Co (franklin Lakes)Catalog number
362761
Lot number
5196721
Product problems
- Break
- Fluid/Blood Leak
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE FOLLOWING FIELDS WERE UPDATED DUE TO A CORRECTION: H.1 IMDRF ANNEX A GRID (1): A0401 - BREAK (1069). INVESTIGATION SUMMARY: BD DID NOT RECEIVE ANY SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 60 RETENTION SAMPLES FROM LOTS 5344609 AND 5196721 WERE VISUALLY INSPECTED ALONG WITH 55 RETENTION SAMPLES FROM LOT 5230375 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 LOTS 5196721, 5230375 AND 5344609, FOR THE INDICATED FAILURE MODE: GLASS BREAKAGE. 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 2 OF 3: IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, 1 TUBE CRACKED CLEANLY DURING CENTRIFUGATION AND CHIPS WERE NOTED IN THE LIP OF THE TUBE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Additional Manufacturer Narrative
B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: BD DID NOT RECEIVE ANY SAMPLES FOR INVESTIGATION. A TOTAL OF 60 RETAINED SAMPLES FROM LOT 5344609 AND 5196721 AND 55 RETAINED SAMPLES FROM LOT 5230375 WERE VISUALLY INSPECTED, WITH NO ISSUES IDENTIFIED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE LOTS 5196721, 5230375 AND 5344609, FOR THE INDICATED FAILURE MODE: DAMAGED. 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. THE BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.
Description of Event or Problem
REPORT 2 OF 3: IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, 1 TUBE CRACKED CLEANLY DURING CENTRIFUGATION AND CHIPS WERE NOTED IN THE LIP OF THE TUBE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.