BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. AS THERE WAS NO SAMPLE OR PHOTO AVAILABLE FOR EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES STARTED TO CRACK FROM THE BOTTOM OF THE TUBE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

Additional Manufacturer Narrative

WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8085590. MEDICAL DEVICE EXPIRATION DATE: 2019-09-30. DEVICE MANUFACTURE DATE: 2018-03-26. MEDICAL DEVICE LOT #: 8054689. MEDICAL DEVICE EXPIRATION DATE: 2019-08-31. DEVICE MANUFACTURE DATE: 2018-02-23. 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 THAT DURING USE OF THE BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES STARTED TO CRACK FROM THE BOTTOM OF THE TUBE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.