BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE
Received Apr 9, 2026 · Event occurred Feb 4, 2026
Report 1917413-2026-00269 · MDR key 24832942
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton Dickinson & Co (franklin Lakes)Catalog number
362761
Lot number
5170619
Product problems
- Short Fill
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, 6 TUBES YIELDED HALF OR LESS THAN HALF FILL. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Additional Manufacturer Narrative
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: BD DID NOT RECEIVE ANY PHOTOS OR SAMPLES FOR INVESTIGATION. A VISUAL INSPECTION WAS CONDUCTED ON 60 RETAINED SAMPLES, AND THE STOPPERS WERE CORRECTLY PLACED ON ALL TUBES. ADDITIONALLY, FUNCTIONAL TESTS WERE PERFORMED ON 10 RETAINED SAMPLES. ALL TUBES WERE FOUND TO BE WITHIN SPECIFICATION LIMITS, WITH NO ISSUES 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 CUSTOMER INDICATED FAILURE MODE: UNDERFILL. 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. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.
Description of Event or Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, 6 TUBES YIELDED HALF OR LESS THAN HALF FILL. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.