BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
Received Jul 9, 2025 · Event occurred Jun 12, 2025
Report 1917413-2025-00884 · MDR key 22461902
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton, Dickinson & Co. (broken Bow)Catalog number
362780
Lot number
4142101
Product problems
- Improper Chemical Reaction
- Improper Chemical Reaction
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED DURING USE OF BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN; AN UNSPECIFIED NUMBER OF TUBES WERE HEMOLYZED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Additional Manufacturer Narrative
D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Additional Manufacturer Narrative
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5. DESCRIBE EVENT OR PROBLEM: "IT WAS REPORTED DURING USE OF BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML, 20 TUBES WERE HEMOLYZED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED." D1. MEDICAL DEVICE BRAND NAME: BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML. D4. MEDICAL DEVICE CATALOG #:362780. D4. MEDICAL DEVICE LOT #:4142101. D4. MEDICAL DEVICE EXPIRATION DATE:31-MAY-2025 . D4. UNIQUE IDENTIFIER (UDI) #:(B)(4). H4. DEVICE MANUFACTURE DATE: 21-MAY-2024.
Description of Event or Problem
IT WAS REPORTED DURING USE OF BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML, 20 TUBES WERE HEMOLYZED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: BD HAD NOT RECEIVED ANY SAMPLES FOR INVESTIGATION. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF JUNE 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. FURTHER TESTING COULD NOT BE PERFORMED AS THE LOT EXPIRED MAY 31, 2025. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: HEMOLYSIS. 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 DURING USE OF BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, AN UNSPECIFIED NUMBER OF TUBES WERE HEMOLYZED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.