LIPASE

Additional Manufacturer Narrative

A BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT (CTS) SPECIALIST ASSISTED CUSTOMER OVER THE PHONE. THE CUSTOMER REPORTED WHEN REMOVING THE OUTER PLASTIC OF CAP, THE ALUMINUM SEAL DID NOT BREAK, MAKING IT DIFFICULT TO ACCESS CONTENT OF VIAL. DUE TO THE DIFFICULTY OF REMOVAL OF SEAL THE OPERATOR USED A SHARP HEMOSTAT TOOL TO ATTEMPT TO REMOVE SEAL FROM BOTTLE. AS A RESULT OF USING THE SHARP TOOL TO REMOVE DIFFICULT SEAL THE OPERATOR SUSTAINED CUTS ON THEIR MIDDLE AND INDEX FINGER WHICH CAUSED BLEEDING. THE OPERATOR IMMEDIATELY WASH THE WOUND WITH WATER AND APPLIED A DRESSING TO STOP THE BLEEDING. DUE TO THE INTENSE PAIN FROM INJURY, MEDICAL ATTENTION WAS REQUIRED BY HEALTH CARE PROFESSIONAL. THE OPERATOR WAS EVALUATED BY HEALTH CARE PROFESSIONAL AND WAS PRESCRIBED TOPICAL OINTMENT TREATMENT. NO ADDITIONAL HARM WAS REPORTED. THE CAUSE OF THE INJURY WAS IDENTIFIED AS OPERATOR USE ERROR. THE CUSTOMER FAILED TO FOLLOW PRECAUTION MEASURES WHEN HANDLING THE REAGENT BOTTLE WHICH RESULTED IN INJURY. PER THE LIPASE REAGENT OSR6130 INSTRUCTION FOR USE, WARNING AND PRECAUTIONS SECTION, IT STATES: " EXERCISE THE NORMAL PRECAUTIONS REQUIRED FOR HANDLING ALL LABORATORY REAGENTS." THE OPERATOR MISSED TWO (2) DAYS OF WORK DUE TO INJURY AND HAS NOW RECOVERED AND RETURNED TO WORK. NO FURTHER ISSUES WERE REPORTED. INITIAL REPORTERS PHONE NUMBER IS (B)(6). THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).

Description of Event or Problem

THE CUSTOMER REPORTED AN OPERATOR SUSTAINED CUT INJURIES TO INDEX AND MIDDLE FINGERS WHEN ATTEMPTING REMOVE METAL SEAL FROM LIPASE REAGENT BOTTLE USING SHARP POINTED HEMOSTATS. THE CUSTOMER REQUIRED MEDICAL INTERVENTION DUE TO BLEEDING AND PAIN CAUSED BY THE INJURY. THE OPERATOR WAS EVALUATED BY MEDICAL PROFESSIONAL WHICH RESULTED IN CLEANING THE WOUND WITH WATER, DRESSING IT, AND PRESCRIPTION OF TOPICAL OINTMENT APPLICATION TO TREAT THE WOUND. THE OPERATOR MISSED TWO DAYS OF WORK DUE TO THE INJURY. THERE WAS NO REPORT OF DEATH ASSOCIATED TO THIS EVENT. NO ADDITIONAL HARM WAS REPORTED.