COULTER LIN-X LINEARITY CONTROL

Description of Event or Problem

POTENTIAL BIOHAZARD EXPOSURE WAS REPORTED; WHILE PERFORMING LINEARITY STUDIES THE OPERATOR WAS MIXING THE COULTER LIN-X LINEARITY CONTROL, AS PER LABELING INSTRUCTIONS, WHEN THE CAP CAME OFF THE VIAL AND THE CONTROL MATERIAL SPILLED OUT. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF LAB COAT AND GLOVES AT THE TIME OF THE INCIDENT. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN LESIONS AND MEDICAL ATTENTION WAS NOT SOUGHT. IT IS UNKNOWN IF THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED, HOWEVER, IT IS READILY AVAILABLE. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS EVENT. THE SPILLED AREA WAS DISINFECTED AND CLEANED UP ACCORDING TO LABORATORY PROTOCOLS.

Additional Manufacturer Narrative

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. THIS EVENT OCCURRED IN THE PREMISES OF BECKMAN COULTER (MIAMI LAKES TRAINING CENTER). SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE ROOT CAUSE FOR THE VIAL LEAKING IS UNKNOWN. HOWEVER, THE PACKAGING ENGINEERING DEPARTMENT REVIEWED AND INSPECTED THE CAPPING/TORQUING PROCESS. IT WAS FOUND THAT THE HEMATOLOGY FILL/CAP/LABEL LINE IS UNDER CONTROL AND THE IN-PROCESS TORQUE REMOVAL TESTS WERE WITHIN VALIDATED SPECIFICATION. RESULTS ALSO SHOWED THAT THE VIALS TESTED COULD BE ADDITIONALLY TIGHTENED 1/4 TO 1/2 TURN IN ORDER TO SECURE THE CAPS FURTHER ALTHOUGH THE CURRENT TORQUE IS WITHIN NORMAL SPECIFICATION. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(6) 2008 AND (B)(6) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.