BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

Additional Manufacturer Narrative

E1. INITIAL REPORTER PHONE #: (B)(6). INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 5 PHOTOS WERE PROVIDED FOR INVESTIGATION. VISUAL EXAMINATION OF THE PHOTOS WAS PERFORMED AND REVEALED POOR BARRIER SEPARATION. THE PRODUCT EXPIRED 31DEC2023; THEREFORE, NO FURTHER TESTING CAN BE COMPLETED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF JUNE 2024. AT THIS TIME, FURTHER TESTING IS NOT INDICATED AND TUBES EXPIRED DECEMBER 2023. 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 HAS BEEN CONFIRMED FOR POOR BARRIER SEPARATION BASED ON THE PHOTOS PROVIDED. AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE INSTRUCTION FOR USE (IFU) CAUTIONS: DO NOT USE TUBES AFTER EXPIRATION DATE PRINTED ON THE TUBE LABEL. 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 CITRATE AN UNSPECIFIED NUMBER OF TUBES FAILED TO SEPARATE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

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: 04-SEP-2024. INVESTIGATION SUMMARY BD RECEIVED EXPIRED SAMPLES ON (B)(6) 2024. 5 PHOTOS WERE ALSO PROVIDED FOR INVESTIGATION. VISUAL EXAMINATION OF THE PHOTOS WAS PERFORMED AND REVEALED POOR BARRIER SEPARATION. THE EXPIRED SAMPLES WERE VISUALLY INSPECTED WITH NO ISSUES OBSERVED. THE PRODUCT EXPIRED 31DEC2023; THEREFORE, NO FURTHER TESTING CAN BE COMPLETED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF (B)(6) 2024. AT THIS TIME, FURTHER TESTING IS NOT INDICATED AND TUBES EXPIRED DECEMBER 2023. 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 HAS BEEN CONFIRMED FOR POOR BARRIER SEPARATION BASED ON THE PHOTOS PROVIDED. AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE INSTRUCTION FOR USE (IFU) CAUTIONS: DO NOT USE TUBES AFTER EXPIRATION DATE PRINTED ON THE TUBE LABEL. 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 CITRATE AN UNSPECIFIED NUMBER OF TUBES FAILED TO SEPARATE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.