BD VACUTAINER® CPT® NC: 1.0ML FICOLL¿: 2.0ML
Received Nov 22, 2024 · Event occurred Feb 8, 2024
Report 1917413-2024-01102 · MDR key 20759297
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton, Dickinson & Co. (broken Bow)Catalog number
362782
Lot number
3320304
Product problems
- Break
- Incorrect, Inadequate or Imprecise Result or Readings
- Break
- 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
IT WAS REPORTED DURING USE OF BD VACUTAINER® CPT® NC: 1.0ML FICOLL¿: 2.0ML 4 TUBES BROKE IN THE CENTRIFUGE RESULTING IN LOSS OF SAMPLES FOR STUDY AND AN UNSPECIFIED NUMBER OF SAMPLES ARE EXHIBITING LOW YIELD. 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.
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: 05-DEC-2024 INVESTIGATION SUMMARY BD RECEIVED 12 SAMPLES FOR INVESTIGATION. OUT OF THESE, 2 USED SAMPLES WERE FOUND TO BE BROKEN, WHILE THE 10 UNUSED SAMPLES WERE INSPECTED AND NO ISSUES WERE IDENTIFIED. THE PRODUCT EXPIRED ON 30 NOV 2024. THE FORMING RECORDS FOR THE GLASS TUBE MANUFACTURING WERE REVIEWED, AND ALL PROCESS INSPECTIONS COMPLY WITH SPECIFICATIONS. FURTHER TESTING CANNOT BE COMPLETED DUE TO EXPIRED MATERIAL. ADDITIONALLY, 60 RETAINED SAMPLES WERE VISUALLY INSPECTED WITH NO ISSUES 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 BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: GLASS BREAKAGE. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: LOW YIELD. 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.
Description of Event or Problem
IT WAS REPORTED DURING USE OF BD VACUTAINER® CPT® NC: 1.0ML FICOLL¿: 2.0ML 4 TUBES BROKE IN THE CENTRIFUGE RESULTING IN LOSS OF SAMPLES FOR STUDY AND AN UNSPECIFIED NUMBER OF SAMPLES ARE EXHIBITING LOW YIELD. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.