COULTER® 4C® PLUS CELL CONTROL

Description of Event or Problem

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ABNORMAL CONTROL VIAL FROM COULTER 4C PLUS CELL CONTROL TRI-PACK THAT WAS DROPPED BY AN OPERATOR AND BROKE. PAPER TOWEL WAS USED TO CLEAN THE CONTROL SPILL. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), AND DID NOT SUSTAIN ANY CUTS OR INJURIES FROM THE BROKEN VIAL. 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

REPLACEMENT PRODUCT WAS PROVIDED. MSDS WAS REVIEWED AND AN EXPOSURE CONTROL PLAN IS IN PLACE. 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.