4C -ES CELL CONTROL

Additional Manufacturer Narrative

PER PRODUCT LABELING: THIS REAGENT SHOULD BE HANDLED AT BIOSAFETY LEVEL 2, AS RECOMMENDED FOR ANY POTENTIALLY INFECTIOUS HUMAN SERUM OR BLOOD SPECIMEN IN THE CENTERS FOR DISEASE CONTROL/NATIONAL INSTITUTES OF HEALTH MANUAL "BIOSAFETY IN MICROBIOLOGICAL AND BIOMEDICAL LABORATORIES," 1988. THE OPERATOR STATED THAT HE WAS UNSURE IF THE CAP WAS NOT ON CORRECTLY OR IF IT WAS CRACKED, BECAUSE WHEN HE NOTICED THE SPILLING, HE DROPPED THE VIAL AND IT BROKE ON THE FLOOR. THE VIAL WAS UNAVAILABLE FOR FURTHER ANALYSIS. ROOT CAUSE FOR THE LEAKAGE IS UNK. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(6) 2008 AND (B)(6) 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

Description of Event or Problem

CUSTOMER REPORTED A POTENTIAL BIOHAZARD EVENT WHILE USING THE 4C -ES CELL CONTROL. WHILE INVERTING THE HIGH LEVEL CONTROL VIAL FOR MIXING, THE VIAL LEAKED ONTO THE OPERATOR'S PANTS AND CAME IN CONTACT WITH HIS SKIN. THERE WAS NO EXPOSURE TO OPEN LESIONS OR MUCOUS MEMBRANES. THE OPERATOR WAS UNSURE WHETHER THE VIAL LEAKED DUE TO A LOOSE CAP OR IF IT WAS CRACKED. THE OPERATOR STATED HE WOULD GO TO THE FACILITY'S OCCUPATIONAL HEALTH OFFICE. IT IS UNK IF TREATMENT WAS REQUIRED WHEN THE OPERATOR WENT TO THE FACILITY'S OCCUPATIONAL HEALTH OFFICE, THEREFORE MEDICAL INTERVENTION MAY HAVE OCCURRED.