4C -ES CELL CONTROL

Additional Manufacturer Narrative

BECKMAN COULTER INC. PRODUCT LABELING STATES THAT PPE MUST BE WORN WHEN HANDLING THE PRODUCT. SPECIFICALLY, LABELING STATES: THIS SPECIMEN/REAGENT SHOULD BE HANDLED AT BIOSAFETY LEVEL 2, AS RECOMMENDED FOR ANY POTENTIALLY INFECTIOUS HUMAN SERUM OR BLOOD SPECIMEN IN THE (B)(6) MANUAL "BIOSAFETY IN MICROBIOLOGICAL AND BIOMEDICAL LABORATORIES," 1988. CUSTOMER CANCELED A PLANNED FIELD SERVICE VISIT TO EVALUATE THE ANALYZER BECAUSE THE OTHER CONTROL VIALS DID NOT LEAK. THE PRODUCT WAS USED FOR APPROX 15 PIERCES BEFORE IT LEAKED. THE OPEN VIAL CLAIM IS THAT THE PROCEDURE LISTED IN THE INSTRUCTIONS FOR USE CAN BE PERFORMED A MAXIMUM OF 20 TIMES WITHIN 35 DAYS. ROOT CAUSE FOR THE FAILURE OF THE VIAL STOPPER WAS NOT DETERMINED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

Description of Event or Problem

CUSTOMER REPORTED A POTENTIAL BIOHAZARD EVENT WHEN A NORMAL CONTROL VIAL OF 4C -ES CELL CONTROL LEAKED FROM THE CAP WHEN USING A COULTER AC-T DIFF 2 ANALYZER ON (B)(6) 2008. THE OPERATOR WAS NOT WEARING PERSONAL PROTECTIVE EQUIPMENT. THE OPERATOR WAS EXPOSED TO THE CONTROL MATERIAL, HOWEVER, THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN LESIONS. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS EVENT.