BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN
Received Dec 16, 2025 · Event occurred Nov 19, 2025
Report 1917413-2025-01673 · MDR key 23821476
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton Dickinson & Co (franklin Lakes)Catalog number
362753
Lot number
5107730
Product problems
- Device Ingredient or Reagent Problem
- Device Ingredient or Reagent Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E.1. INITIAL REPORTER FACILITY NAME: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, 2 TUBES EXHIBITED POOR BARRIER SEPARATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Description of Event or Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, 2 TUBES EXHIBITED POOR BARRIER SEPARATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: BD RECEIVED 2 PHOTOS FOR INVESTIGATION. UPON EVALUATION, THE TWO PHOTOS SHOWED THE ENCLOSED CASE AND AN OPEN CASE OF THE PRODUCT; HOWEVER, THEY DID NOT DISPLAY THE CUSTOMER¿S INDICATED FAILURE MODE. ADDITIONALLY, A TOTAL OF 60 RETAINED SAMPLES WERE VISUALLY INSPECTED, AND NO ISSUES WERE IDENTIFIED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF NOVEMBER 2025. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. 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 INDICATED FAILURE MODE: POOR BARRIER SEPARATION. 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. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.