BD VACUTAINER® CPT® NC: 1.0ML FICOLL¿: 2.0ML
Received Apr 10, 2025 · Event occurred Mar 13, 2025
Report 1917413-2025-00438 · MDR key 21817342
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton, Dickinson & Co. (broken Bow)Catalog number
362782
Lot number
UNKNOWN
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
Description of Event or Problem
REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® CPT® NC: 1.0ML FICOLL¿: 2.0ML, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBITED POOR BARRIER SEPARATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Additional Manufacturer Narrative
B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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.
Description of Event or Problem
REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® CPT® NC: 1.0ML FICOLL¿: 2.0ML, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBITED POOR BARRIER SEPARATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: BD RECEIVED ONE PHOTO FOR INVESTIGATION. THE PHOTO WAS VISUALLY EXAMINED AND REVEALED POOR BARRIER SEPARATION. COMPLAINTS FOR SAMPLE QUALITY WERE NOT UNDER STATISTICAL CONTROL FOR THE MONTH OF MARCH 2025, ADDITIONAL TESTING MAY BE REQUIRED. THE LOT ASSOCIATED WITH THE COMPLAINT EXPIRED ON 31 DEC 2024. FURTHER TESTING COULD NOT BE PERFORMED ON EXPIRED PRODUCTS. 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.