BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
Received Aug 15, 2025 · Event occurred Jul 25, 2025
Report 1917413-2025-01113 · MDR key 22819636
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton, Dickinson & Co. (broken Bow)Catalog number
362780
Lot number
5107761
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
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 ANY SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, A TOTAL OF 60 RETAINED SAMPLES WERE INSPECTED, WITH NO ISSUES BEING IDENTIFIED. FURTHER CLINICAL TESTING COULD NOT BE CONDUCTED AS BD CLINICAL LABORATORIES ARE CURRENTLY UNABLE TO TEST CPT TUBES FOR THE ERRONEOUS RESULTS- (YIELD AND VIABILITY). BD WILL CONTINUE TO TRACK FOR ADDITIONAL COMPLAINTS AND EMERGING TRENDS. 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: ERRONEOUS RESULTS (YIELD AND VIABILITY). 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.
Description of Event or Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML IN A STUDY, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBITED LOW YIELD AND VIABILITY. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Additional Manufacturer Narrative
E1. INITIAL REPORTER PHONE #: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML IN A STUDY, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBITED LOW YIELD AND VIABILITY. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.