COULTER 5C CELL CONTROL, TRI-PACK

Description of Event or Problem

THE CUSTOMER HAD CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT THAT A VIAL OF THEIR COULTER 5C CELL CONTROL, TRI-PACK LEAKED A FEW DROPS WHILE MIXING ON THE LABORATORY'S ROCKER MIXER. THE CUSTOMER REPORTED THAT THE RUBBER STOPPER ON THE TOP OF THE CONTROL VIAL HAD DISLODGED FROM THE VIAL AFTER SEVERAL PIERCINGS FROM THEIR COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (I.E., GLOVES) AT THE TIME OF THE EVENT. 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. THERE WAS NO SPILL ON THE COUNTER OR ON THE FLOOR. THE LABORATORY HAS A RISK MANAGEMENT PLAN IN PLACE. IT IS UNKNOWN IF THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED AT THE TIME OF THE EVENT.

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 NEEDLE ON THE ANALYZER WAS EXCHANGED. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. 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 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.