BD VACUTAINER® CPT NH: 130 IU FICOLL 2.0ML
Received Nov 17, 2025 · Event occurred Oct 27, 2025
Report 1917413-2025-01561 · MDR key 23578014
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton, Dickinson & Co. (broken Bow)Catalog number
362780
Lot number
4346569
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: BD HAD NOT RECEIVED ANY SAMPLES OR PHOTOS FOR THE INVESTIGATION. A TOTAL OF 60 RETAIN SAMPLES WERE VISUALLY INSPECTED, AND NO ISSUES WERE IDENTIFIED. 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 NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: GLASS BREAKAGE DURING CENTRIFUGATION. 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.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® CPT NH: 130 IU FICOLL 2.0ML, ONE OF THE TUBES BROKE DURING CENTRIFUGATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
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 THAT WHILE USING THE BD VACUTAINER® CPT NH: 130 IU FICOLL 2.0ML, ONE OF THE TUBES BROKE DURING CENTRIFUGATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.