COULTER FLOW COUNT

Description of Event or Problem

THE CUSTOMER REPORTED THAT WHEN HE WAS REMOVING THE FOIL FROM THE TOP OF A VIAL OF FLOW-COUNT WITH SCISSORS, HE CUT THE INDEX FINGER OF HIS LEFT HAND. AT THE TIME OF THE INJURY HE WAS WEARING A LAB COAT AND GOGGLES BUT HE WAS NOT WEARING GLOVES AS INSTRUCTED IN BOTH THE MSDS (MATERIAL SAFETY DATA SHEET) AND PRODUCT'S INSTRUCTIONS FOR USE. THE OPERATOR SOUGHT FIRST AID FOR THE CUT ON HIS FINGER. THE WOUND WAS CLEANED WITH ALCOHOL WITH A BAND-AID APPLIED. HE RETURNED TO WORK THE SAME DAY. COULTER FLOW COUNT IS USED IN CONJUNCTION WITH THE COULTER FC 500 FLOW CYTOMETER.

Additional Manufacturer Narrative

THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED FOR THE PERIOD BETWEEN (B)(4), 2008 AND (B)(4), 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. PER THE FLOW COUNT PACKAGE INSERT SHEET (PN (B)(4)) STATEMENT OF WARNINGS: THIS REAGENT CONTAINS 1 PERCENT FORMALDEHYDE. AVOID CONTACT WITH SKIN AND EYES AS FORMALDEHYDE MAY CAUSE IRREVERSIBLE EFFECTS TO THESE TISSUES. DO NOT BREATHE VAPORS. WEAR APPROPRIATE SAFETY EQUIPMENT SUCH AS GLOVES AND EYE PROTECTION. ALL THE ALUMINUM FROM THE HEAT SEAL MUST BE REMOVED FROM THE TOP OF THE BOTTLE. RESIDUAL ALUMINUM REACTS WITH THE FORMALDEHYDE AND MAY CAUSE A CHANGE IN THE APPEARANCE OF THE FLOW-COUNT FLUOROSPHERES. FIELD SERVICE WAS NOT DISPATCHED FOR THIS EVENT. ROOT CAUSE MAY BE ATTRIBUTED TO IMPROPER LABORATORY PRACTICES.