CUSTOM HEALTHCARE SYSTEMS, INC

Description of Event or Problem

BONE MARROW BIOPSY KIT FAILURE RESULTING IN COMPROMISED SPECIMEN. WHILE PERFORMING A BONE MARROW BIOPSY ON THIS PATIENT, THE CUTTING NEEDLE TWISTED TO SUCH AN EXTENT THAT IT WAS BENT AND CLOSED OFF AND THE BONE MARROW CORE COULD NOT BE REMOVED IN STANDARD FASHION. MUCH OF THE CORE BECAME FRAGMENTED AND CRUSHED WHILE TRYING TO FREE IT FROM THE CUTTING NEEDLE, AND THE REMAINING CORE WAS NOT ABLE TO BE INTERPRETED BY THE PATHOLOGIST. THE PATIENT MAY REQUIRE THE PROCEDURE TO BE REPEATED DUE TO THE DEVICE FAILURE.