BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN
Received Dec 10, 2024 · Event occurred Nov 15, 2024
Report 1917413-2024-01183 · MDR key 20893128
Device
Generic name
Lymphocyte Separation Medium
Manufacturer
Becton, Dickinson & Co. (broken Bow)Catalog number
362753
Lot number
4197915
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
Additional Manufacturer Narrative
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 22-NOV-2024. INVESTIGATION SUMMARY: BD RECEIVED FIVE (5) SAMPLES FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED. ADDITIONALLY, FIFTY-NINE (59) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED AS ALL SAMPLES MET SPECIFICATIONS. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF NOVEMBER 2024. 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. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE OF POOR BARRIER SEPARATION. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.
Description of Event or Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, 2 TUBES DID NOT SEPARATE PROPERLY. A NEW LOT WAS USED WITHOUT ISSUE. 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¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN, 2 TUBES DID NOT SEPARATE PROPERLY. A NEW LOT WAS USED WITHOUT ISSUE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.