AW TRANSFER SET FOR BACT ALERT

Description of Event or Problem

IT WAS REPORTED TO COVIDIEN ON (B)(6) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A BLOOD COLLECTION TRANSFER SET. THE CUSTOMER REPORTS THAT THE CONNECTION IS LOOSE AND COMES APART, SPILLING BLOOD DURING PROCEDURES. THE CUSTOMER REPORTED THE FEMALE CONNECTOR COMES OUT OF THE SAFETY TRANSFER DOME UPON REMOVAL OF THE SYRINGE. THE CUSTOMER STATED THE SYRINGE IS PULLED OUT, WHILE HOLDING ON TO THE TRANSFER DOME, AND THE FEMALE CONNECTOR IS PULLED OFF WITH THE SYRINGE, EXPOSING THE NEEDLE TIP. AT THE TIME OF THE INCIDENT, THE PHLEBOTOMIST RECEIVED A DIRTY NEEDLE STICK, AS THE DEVICE HAD DRAGGED ACROSS THE WRIST WHICH WAS HOLDING THE SAFETY TRANSFER DOME.

Additional Manufacturer Narrative

(B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.