Description of Event or Problem · 1
ON (B)(6) 2018, UPON COMPLETION OF PROCEDURE, VERTOS SALES REP NOTICED THAT THE DEMONSTRATION KIT TRAY WAS OPEN AND WHITE PEEL COVER FOLDED OVER AND THE INNER TRAY WITH KIT CONTENTS WERE GONE. IT WAS CONFIRMED BY THE SCRUB TECH AND CIRCULATING NURSE THAT DEMO KIT CONTENTS HAD BEEN USED ON THE PATIENT. IT WAS LATER DETERMINED THAT THERE WAS A BREAKDOWN IN PROTOCOL AND COMMUNICATION BETWEEN SCRUB TECH AND CIRCULATING NURSE. THE SCRUB NURSE LEFT STERILE FIELD AND REMOVED NON-STERILE DEMONSTRATION KIT WHICH WAS LABELED "NOT FOR HUMAN USE", FROM NON-STERILE FIELD AND PROVIDED THE PHYSICIAN WITH THE NON-STERILE KIT CONTENTS. THE CIRCULATING NURSE SHOULD HAVE SUPPLIED THE SCRUB NURSE WITH A STERILE KIT, BUT WAS NOT PRESENT TO DO SO. THE PATIENT WAS IMMEDIATELY TREATED WITH ANTIBIOTICS AND ADMITTED TO THE HOSPITAL WHERE THE PROCEDURE HAD TAKEN PLACE. LATER IN THE DAY, FOLLOW UP INFORMATION STATED THAT PATIENT WAS DOING WELL AND UP AND WALKING AROUND WITHOUT ISSUE. THERE WERE NO SIGNS OF FEVER OR ANYTHING REMARKABLE ON HER BLOOD TEST. AN INFECTIOUS DISEASE PHYSICIAN SAW HER AND ALL LABS AT THAT POINT HAD BEEN NORMAL. THE PATIENT CONTINUED TO DO WELL AND WAS DISCHARGED ON (B)(6) 2018 WITH IV ANTIBIOTICS VIA PICC LINE FOR 10 DAYS AND A HOME HEALTH NURSE. ALL TESTS HAD BEEN GOOD TO DATE AND NO SIGNS OF FEVER. THE PROCEDURE WAS SUCCESSFUL AS PATIENT STATED THAT HER LEG AND BUTTOCKS PAIN WAS NO LONGER THERE.