POLYMEDCO SEDCHEK (ABNORMAL)

Additional Manufacturer Narrative

THE LABELING AND CERTIFICATE OF ANALYSIS INDICATES THAT "EACH DONOR UNIT USED IN PREPARATION OF SED-CHEK 2 HAS BEEN TESTED AND FOUND TO BE NON-REACTIVE FOR ANTIBODIES." THE LABELING STATES THAT "BECAUSE NO TEST METHOD CAN OFFER COMPLETE ASSURANCE OR OTHER INFECTIOUS AGENTS ARE ABSENT, IT IS RECOMMENDED THAT HUMAN BLOOD BASED PRODUCT BE HANDLED WITH THE SAME PRECAUTIONS USED FOR ANY POTENTIALLY BIOHAZARDOUS PTS SPECIMENS."

Description of Event or Problem

A LAB TECH DROPPED THE POLYMEDCO SEDCHEK 2 (ABNORMAL) GLASS VIAL ON THE FLOOR. THE GLASS VIAL BROKE AND THE TECH PICKED UP THE PIECES OF GLASS WITH GLOVES AND IN THE PROCESS, CUT HIS FINGER. NO HOSPITALIZATION WAS NECESSARY. THIS WAS REPORTED TO THE INFECTION CONTROL DEPARTMENT WITHIN THE FACILITY.