80NGT HOSPIRA,INC.

REPORT 1 OF 2. THE CUSTOMER CONTACT REPORTED AN ADVERSE EVENT WHILE THE DEVICE WAS IN USE. THIS IS A COMBINATION PRODUCT THAT IS BEING REPORTED FOR THE DRUG PORTION OF THE PRODUCT. AT AN UNSPECIFIED TIME, THE HOMECARE PATIENT RECEIVED AN UNSPECIFIED VOLUME OF HEPARIN LOCK FLUSH SOLUTION, USP 100UNITS/ML (EXPIRATION DATE: 03/01/2009) TO FLUSH A BROVIAC CATHETER. IT WAS REPORTED, THE PATIENT DEVELOPED AN INSTANT SEVERE HEADACHE AND A BURNING SENSATION THAT LASTED FOR "15-20 MINUTES." THE PATIENT WAS HOSPITALIZED. TREATMENT WAS NOT REPORTED; HOWEVER, THE CUSTOMER CONTACT STATED THAT PATIENT CONTINUED TO RECEIVED HEPARIN FLUSHES. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.