BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
Received Jul 22, 2025 · Event occurred Jun 23, 2025
Report 1917413-2025-00945 · MDR key 22568694
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton, Dickinson & Co. (broken Bow)Catalog number
362780
Lot number
4290152
Product problems
- Short Fill
- Short Fill
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: 17-JUL-2025. INVESTIGATION SUMMARY: BD RECEIVED 3 SAMPLES FOR INVESTIGATION. THE 3 SAMPLES WERE VISUALLY INSPECTED, AND THE INDICATED FAILURE MODE WAS NOT OBSERVED. FURTHERMORE, THE SAMPLE TUBES WERE DRAW TESTED AND ALL TUBES WERE WITHIN SPECIFICATION LIMITS. ADDITIONALLY, 10 RETAINED TUBES WERE DRAW TESTED AND ALL TUBES WERE WITHIN SPECIFICATION LIMITS. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODES: UNDERFILL AND NO FILL/NO VACCUUM. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. 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 IDENTIFICATION OF EMERGING TRENDS.
Description of Event or Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML, AN UNSPECIFIED NUMBER OF TUBES ARE UNDERFILLED. SOME TUBES ARE REPORTED TO NOT FILL AT ALL. 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.
Description of Event or Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML, AN UNSPECIFIED NUMBER OF TUBES ARE UNDERFILLED. SOME TUBES ARE REPORTED TO NOT FILL AT ALL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.