COULTER® 4C® PLUS CELL CONTROL

Description of Event or Problem

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN OPEN CONTROL VIAL FROM COULTER 4C PLUS CELL CONTROL TRI-PACK THAT WAS KNOCKED ONTO THE FLOOR AND THE CONTENTS OF THE VIAL SPILLED OUT. THE CONTROL VIAL CAP WAS OPEN AND THE VIAL DID NOT SHATTER UPON IMPACT WITH THE FLOOR. THE CUSTOMER CLEANED UP THE SPILL WITH SURFACE DISINFECTANT AND DECONTAMINATE CLEANER. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), AND THERE WAS NO EXPOSURE TO EYES, MOUTH, OR OPEN WOUNDS. NO DEATH OR INJURY WAS REPORTED FOR THIS EVENT. NO ONE SOUGHT MEDICAL ATTENTION, AND THERE WAS NO EFFECT TO ANY PATIENTS OR TO THE USER.

Additional Manufacturer Narrative

MSDS WAS NOT REVIEWED, BUT IS AVAILABLE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. PER PRODUCT LABELING, BECKMAN COULTER, INC. (BCI) URGES CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING AUTOMATED LABORATORY ANALYZER. A ROOT CAUSE FOR THIS EVENT WAS AN OPERATOR ERROR.