VACUTAINER CPT
Received Oct 22, 2025 · Event occurred Sep 23, 2025
Report 1917413-2025-01452 · MDR key 23356911
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton, Dickinson & Co. (broken Bow)Catalog number
362753
Lot number
5020005
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
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES . H.3 DEVICE EVAL BY MANUFACTURER? YES . D9: RETURNED TO MANUFACTURER ON: 02-OCT-2025. INVESTIGATION SUMMARY: BD RECEIVED FIVE SAMPLES AND 15 PHOTOS FOR INVESTIGATION. THE SAMPLES WERE VISUALLY INSPECTED WITH NO ISSUES IDENTIFIED. THE EVALUATION OF THE PHOTOS SHOWED THE PRESENCE OF POOR BARRIER SEPARATION. COMPLAINTS FOR SAMPLE QUALITY WERE NOT UNDER STATISTICAL CONTROL FOR THE MONTH OF SEPTEMBER 2025, ADDITIONAL TESTING WAS PERFORMED. FACTORS THAT MAY CONTRIBUTE TO POOR BARRIER SEPARATION WERE EVALUATED THROUGH A CLINICAL STUDY TO VERIFY THE DESIGN OF THE DEVICE MET IT¿S INTENDED USE. THE RESULT OF THE STUDY SHOWED THAT THE DEVICE PERFORMED AS EXPECTED AND WE WERE UNABLE TO DETERMINE ANY EXTERNAL CONTRIBUTOR TO THIS REPORTED ISSUE: NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES EXHIBITED PROPER FILL. BD WAS UNABLE TO DUPLICATE THE CUSTOMER¿S INDICATED FAILURE (POOR BARRIER SEPARATION) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. REPLICATES OF BOTH CUSTOMER RETURN AND CONTROL SAMPLES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL VISUAL OBSERVATIONS EVALUATED. ALL TUBES PERFORMED 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 PHOTOS 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. 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 HEPARIN, AN UNSPECIFIED NUMBER OF TUBES EXHIBITED POOR BARRIER SEPARATION AFTER PROCESSING. SAMPLES WERE RECOLLECTED. THERE WAS NO OTHER 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.
Description of Event or Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, AN UNSPECIFIED NUMBER OF TUBES EXHIBITED POOR BARRIER SEPARATION AFTER PROCESSING. SAMPLES WERE RECOLLECTED. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.