BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
Received Aug 22, 2024 · Event occurred Jul 15, 2024
Report 1917413-2024-00761 · MDR key 20035052
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton, Dickinson & Co. (broken Bow)Catalog number
362780
Lot number
3354407
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
INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 44 RETENTION SAMPLES FROM BD INVENTORY WERE VISUALLY INSPECTED WITH NO ISSUES 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 OTHER COMPLAINT HAS BEEN RECEIVED ON THIS LOT NUMBER FOR THE REPORTED DEFECT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE REPORTED DEFECT. 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.
Description of Event or Problem
REPORT 10 OF 15. IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ NH: ~130 U FICOLL¿: 2.0ML IN A STUDY COMPARING CPT TUBES TO LEUCOSEP TUBES, CELL YIELDS AND CELL VIABILITY WERE LOWER THAN EXPECTED IN A DONOR SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.