BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
Received Apr 3, 2025 · Event occurred Mar 6, 2025
Report 1917413-2025-00390 · MDR key 21763630
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton, Dickinson & Co. (broken Bow)Catalog number
362780
Lot number
4197927
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 RECEIVED ONE PHOTO FOR INVESTIGATION. A VISUAL EXAMINATION OF THE PHOTO REVEALED POOR BARRIER SEPARATION. COMPLAINTS FOR SAMPLE QUALITY WERE NOT UNDER STATISTICAL CONTROL FOR THE MONTH OF MARCH 2025, ADDITIONAL TESTING WAS PERFORMED: NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES EXHIBITED PROPER FILL. BD WAS UNABLE TO DUPLICATE THE CUSTOMER¿S INDICATED FAILURE (POOR SEPARATION) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. REPLICATES OF BOTH RETENTION AND CONTROL SAMPLES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL VISUAL OBSERVATIONS EVALUATED. ALL TUBES PERFORMED DEMONSTRATED DISTINCT LAYERS AS EXPECTED. 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 BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: POOR BARRIER SEPARATION BASED ON THE PHOTO PROVIDED. 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.
Description of Event or Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML, POOR BARRIER SEPARATION WAS OBSERVED IN 6 TUBES. TUBES WERE RE-SPUN AND 2 TUBES STILL HAD POOR BARRIER SEPARATION (8 TOTAL OCCURRENCES). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Description of Event or Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ NH: 130 IU FICOLL¿: 2.0ML, POOR BARRIER SEPARATION WAS OBSERVED IN 6 TUBES. TUBES WERE RE-SPUN AND 2 TUBES STILL HAD POOR BARRIER SEPARATION (8 TOTAL OCCURRENCES). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Additional Manufacturer Narrative
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.