4C PLUS COULTER CELL CONTROL

Additional Manufacturer Narrative

THE MSDS WAS NOT REVIEWED, HOWEVER IT IS READILY AVAILABLE. THE LAB'S EXPOSURE CONTROL OR RISK MANAGEMENT PLANS ARE IN PLACE. PER LABELING, 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 IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. THE CONTROL TUBE WAS NOT REPLACED SINCE THE DAMAGED VIAL HAD BEEN PREVIOUSLY USED AND WAS ALREADY HALF AT THE TIME OF THE EVENT. THE ROOT CAUSE OF THE LEAK IS UNKNOWN. BEC INTERNAL NUMBER: (B)(4).

Description of Event or Problem

A CUSTOMER REPORTED TO BECKMAN COULTER INC. (BEC) THAT THE 4C PLUS COULTER CELL CONTROL TUBE WAS LEAKING. PER THE CUSTOMER, THE CONTROL HAD BEEN USED TWICE IN PREVIOUS OCCASIONS AND WAS HALF FULL WHEN THE INCIDENT OCCURRED. THE CONTROL WAS STORED IN A CUP IN THE REFRIGERATOR. THE CUSTOMER PICKED UP THE GLASS TUBE TO WIPE THE LEAK, THE GLASS VIAL BROKE AND THE CONTENTS SPILLED. THE CUSTOMER DID NOT CUT HERSELF WITH THE BROKEN GLASS NOR WAS EXPOSED TO THE CONTENTS OF THE CONTROL TUBE. THE USER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF LAB COAT AND GLOVES AT THE TIME OF THE EVENT. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THERE WAS NO CHANGE TO PATIENT TREATMENT ATTRIBUTED OR ASSOCIATED TO THIS COMPLAINT.