VITROS CALIBRATOR KIT 2

Additional Manufacturer Narrative

INVESTIGATION INTO THIS EVENT DETERMINED THAT THE BOTTLE BROKE WHILE THE METAL SEAL WAS BEING REMOVED. PRIOR TO BREAKAGE, THERE WAS NO EVIDENCE OF THE BOTTLE BEING DAMAGED. THE ROOT CAUSE OF THIS EVENT IS UNK.

Description of Event or Problem

A CUSTOMER WAS CUT ON THE HAND WHILE OPENING A DILUENT BOTTLE OF CALIBRATOR KIT 4 OR 2. THE CUSTOMER RECEIVED MEDICAL ATTENTION FOR THE CUT, WHERE THE HAND WAS WASHED AND BANDAGED, AND THE EMPLOYEE RECEIVED A TETANUS SHOT. THE EMPLOYEE WAS RELEASED TO RETURN TO WORK. NO COMPLICATIONS HAVE BEEN REPORTED. EXPOSURE TO THE BOTTLE CONTENTS COULD CAUSE IRRITATION TO THE SKIN, EYES AND RESPIRATORY SYSTEM. THIS IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE SUBJECT RECEIVED A TETANUS SHOT DUE TO THE INJURY. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.