XODUS MEDICAL

Description of Event or Problem

USER NOTICED THAT THE CUSTOM LABELS IN THE ANGIO-SPECIAL PROCEDURE PACK FLAKE OFF WHEN THE SYRINGES ARE LEFT IN A SALINE BOWL. THIS DOES NOT HAPPEN VERY OFTEN IN THE CATH LAB, BUT THERE IS A POSSIBILITY THAT A TECH COULD LEAVE A SYRINGE IN THE WIRE BOWL AND THIS WOULD HAPPEN. WE SAW THIS IN THE OR WHEN WE ARE WORKING ON AN EVAR PROCEDURE. THE SURGERY TECHS LEAVE THE SYRINGES IN THE FLUSH BOWL UNTIL THE MD NEEDS ONE. IN DOING THIS THE LABELS FLAKE APART. WE HAVE HAD TO DISCARD FLUID OFF OF THE SCRUB TABLE IN TWO PROCEDURES NOW. WE NOW REALIZE WHAT IS CAUSING THE PROBLEM AND HAVE DISCUSSED WITH THE SURGERY TECHS TO NOT USE THE LABELS THAT ARE PROVIDED IN THE ANGIO-SPECIAL PROCEDURE PACKS. THIS IS AN INCONVENIENCE, BUT I AM MORE CONCERNED WITH THE POSSIBILITY OF THIS HAPPENING DURING OTHER PROCEDURES AND THESE PARTICLES GETTING INJECTED INTO A PATIENT'S ARTERY. CUSTOM LABEL NSCL23635, LOTS: 200203, 170913, 170703 FROM XODUS MEDICAL WERE PLACED INSIDE ROI CPS, LLC ANGIO SPECIAL PROCEDURE CUSTOM PACK 800701002 (HT00906B), LOT: 77188B.