COULTER 4C CELL CONTROL, TRI-PACK

Additional Manufacturer Narrative

PRODUCT LABELING STATES: "BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER." THE CONTROL VIAL WAS DISPOSED OF THE CUSTOMER INTO A BIOHAZARD SHARPS CONTAINER. THE ROOT CAUSE WAS NOT DETERMINED. PRODUCT LABELING CONTAINS SUFFICIENT WARNINGS/PRECAUTIONS ADDRESSING POTENTIAL BIOHAZARD EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 01, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

Description of Event or Problem

THE CUSTOMER HAD CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT THAT A VIAL OF THEIR COULTER 4C CELL CONTROL, TRI-PACK LEAKED DUE TO A CRACK IN THE CAP WHILE MIXING THE VIAL BEFORE ASSAYING. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF THE EVENT. APPROXIMATELY 1 ML OF COULTER 4C CELL CONTROL LEAKED ONTO THE CUSTOMER'S PANT LEG, SHOES, AND THE FLOOR. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN LESIONS. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. MEDICAL ATTENTION WAS NOT SOUGHT. THE LABORATORY HAS A RISK MANAGEMENT PLAN IN PLACE. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS AVAILABLE, BUT WAS NOT REVIEWED BY THE CUSTOMER AT THE TIME OF THE EVENT.