inforMED
InjuryKSS

SAMPLINK

Received Aug 29, 1996 · Event occurred Jul 8, 1996

Report 9611423-1996-00001 · MDR key 36800

Device

Generic name

Blood Sampling Device

Model number

*

Catalog number

4RY215

Lot number

UNK

Patient

UNKNOWN

Narrative

Description of Event or Problem

ON 8/14/96 CO RECEIVED A COPY OF A MEDWATCH REPORT ISSUED BY CO. REPORT NUMBER USF 9608060001-DESCRIBING AN ADVERSE EVENT INVOLVING THE USE OF ANOTHER C PRODUCT IN CONJUNCTION WITH REPORTING CO'S PRODUCT (CODE 4R4215)- THE REPORT ENCLOSED A COPY OF THAT REPORT, DESCRIBING THE EVENT: AN OPERATOR WAS SPRAYED WITH BLOOD IN THE MOUTH WHEN HOLDING THE DEVICE TO THE LAB SITE INTERGAL COMPONENT IN THE CO BLOOD PACK UNIT.