4C PLUS COULTER CELL CONTROL

Description of Event or Problem

CUSTOMER REPORTED A POTENTIAL BIOHAZARD WHEN THE CAP OF THE LOW CONTROL VIAL OF THE 4C PLUS COULTER CELL CONTROL WAS LEAKING. WHEN PUNCTURED, THE CONTROL CONTENTS SPLATTERED ONTO THE INSTRUMENT AND OPERATOR. THE OPERATOR WAS WEARING GLOVES. THE OPERATOR WAS NOT WEARING A LAB COAT OR EYE PROTECTION. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. THERE WAS NO EXPOSURE TO OPEN LESIONS OR MUCOUS MEMBRANES. THE SPILL WAS CLEANED IN ACCORDANCE WITH THE LABORATORY'S PROCEDURES. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS 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." PRODUCT WAS NOT RETURNED FOR EVAL. THE PRODUCT WAS DISCARDED BY THE CUSTOMER. ROOT CAUSE WAS DETERMINED. PRODUCT LABELING CONTAINS SUFFICIENT WARNINGS/PRECAUTIONS FOR POTENTIAL BIOHAZARD EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.