Description of Event or Problem · 1
ON FRIDAY, OCTOBER 2, 1998, A PHARMACEUTICAL DISTRIBUTOR IN VIRGINIA CONTACTED AUTOMATIC LIQUID PACKAGING, INC (ALP) TO REPORT AN ADVERSE EVENT. THE DISTRIBUTOR REPORTED TO AUTOMATIC LIQUID PACKAGING, INC THAT A HOME HEALTH CARE PT WITH A SURGICALLY PLACED TRACHEOSTOMY TUBE (T-TUBE) DEVELOPED A TRACHEA INFECTION OF RALSTONIA PICKETTII. AUTOMATIC LIQUID PACKAGING, INC WAS CONTACTED SINCE CO IS THE MFR OF THE UNIT DOSE SALINE THE HOME HEALTH CARE PT IS CURRENTLY USING TO FLUSH HER T-TUBE. AFTER DIRECTLY CONTACTING THE PT, DISTRIBUTOR RELAYED THE FOLLOWING: THE PT UTILIZES THE AUTOMATIC LIQUID PACKAGING, INC 5.0 ML 0.9% SODIUM CHLORIDE UNIT DOSE VIALS TO FLUSH OUT HER T-TUBE TWICE DAILY (10 ML IN THE MORNING AND 10 ML IN THE EVENING). APPROXIMATELY THREE WEEKS AGO SHE DEVELOPED A TRACHEA INFECTION THAT WAS DIAGNOSED AS R PICKETTII. THE PT HAS BEEN USING 5ML 0.9% SALINE FOR TWO YEARS, ALTHOUGH THIS IS THE FIRST TIME SHE HAS DEVELOPED AN INFECTION. IN ADDITION, THE PT RINSES HER T-TUBE EVERY FEW MONTHS BY IMMERSING THE TUBE INTO LISTERINE MOUTHWASH. ABOUT FIVE TO SIX WEEKS AGO SHE DEPLETED HER PROPHYLACTIC ANTIBIOTIC (AZITHROCIN) SHE HAD BEEN TAKING SINCE THE T-TUBE WAS PLACED IN THE TRACHEA. ON OR ABOUT SEPTEMBER 10, 1998, SHE DEVELOPED THE R PICKETTII INFECTION, AS WELL AS OTHER TYPES OF TRACHEAL INFECTIONS, WHICH ACCORDING TO THE PT WERE NOT IDENTIFIED. SHE WAS THEN DIRECTED TO TAKE THE ANTIBIOTIC, AUGMENTIN. AS OF THIS REPORT, PT IS PRESENTLY TAKING THIS ANTIBIOTIC, AND THE R PICKETTII AS WELL AS THE OTHER INFECTIONS HAVE BEEN ELIMINATED FROM HER TRACHEA/THROAT AREA.