COULTER 4C PLUS CELL CONTROL TRI-PACK

Description of Event or Problem

THE CUSTOMER HAD CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT THAT A VIAL OF HIGH LEVEL CONTROL OF COULTER 4C PLUS CELL CONTROL TRI-PACK WAS ACCIDENTLY DROPPED WHEN REMOVING IT FROM THEIR COULTER AC-T DIFF 2 ANALYZER. THE CUSTOMER REPORTED THAT THE VIAL HAD SHATTERED WHEN IT HIT THE FLOOR SPILLING THE CONTENTS OF THE VIAL ONTO THE FLOOR. THE CUSTOMER REPORTED THAT APPROXIMATELY 2.5 ML OF THE HIGH LEVEL CONTROL SPILLED. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (I.E., LAB COAT, GLOVES, AND EYE PROTECTION) 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. THE CUSTOMER CLEANED UP THE SPILL FOLLOWING THEIR INTERNAL BIOHAZARDOUS SPILL PROCEDURE. THERE IS A RISK MANAGEMENT PLAN IN PLACE FOR THE LABORATORY. BEC FAXED THE MATERIAL SAFETY DATA SHEET (MSDS) TO THE CUSTOMER FOR REVIEW.

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." SERVICE WAS NOT DISPATCHED FOR THIS EVENT. PRODUCT WAS NOT RETURNED FOR EVALUATION (VIAL SHATTERED AFTER BEING DROPPED ON THE FLOOR). THE ROOT CAUSE FOR THIS EVENT IS ATTRIBUTABLE TO OPERATOR ERROR. PRODUCT LABELING CONTAINS SUFFICIENT WARNINGS/PRECAUTIONS ADDRESSING POTENTIAL BIOHAZARD EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.