BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

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: 08-FEB-2026. H.1. DEVICE MANUFACTURE DATE: 01-MAR-2025. INVESTIGATION SUMMARY: BD RECEIVED 13 SAMPLES AND 3 PHOTOS FOR INVESTIGATION. A REVIEW OF THE SAMPLES AND PHOTOS INDICATED AIR BUBBLES IN THE GEL OF THE TUBES. 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: GEL AIR BUBBLES-BEFORE USE. 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 PRIOR TO USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, 100 TUBES CONTAINED GEL AIR BUBBLES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

Additional Manufacturer Narrative

E.1. INITIAL REPORTER FACILITY NAME: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED PRIOR TO USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, 100 TUBES CONTAINED GEL AIR BUBBLES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.