Description of Event or Problem · 1
ON OR BEFORE (B)(6) 2011, FDA RECALLED TRIAD'S POVIDONE IODINE PREP PAD BECAUSE OF CONTAMINATION WITH ANTIBIOTIC RESISTANT BACTERIA IN THE PAD MATERIAL. THE COMPANY THAT SUPPLIES MY STERILE CATHETER INSERTION KITS HAS PROVIDED TO ME THE PREP PADS TO BE USED OUTSIDE OF THE STERILE INSERTION TRAY, ONLY. THEY HAVE NOT REPLACED THE ENTIRE STERILE INSERTION KIT. I USE A STERILE CATHETER INSERTION KIT THAT CONTAINS THE RECALLED POVIDONE IODINE PREP PAD. THE COMPANY THAT SUPPLIES MY STERILE CATHETER INSERTION KIT HAS FAILED TO REPLACE THE ENTIRE STERILE CATHETER INSERTION KIT, THEY HAD SUPPLIED ME WITH THE PREP PAD MANUFACTURED BY A DIFFERENT COMPANY BY SUPPLYING BOXES OF PREP PADS IN INDIVIDUAL 2FL X 2FL FOIL PACKETS THAT ARE IMPOSSIBLE TO OPEN AND KEEP STERILE. TO USE THE INDIVIDUAL 2FL X 2FL FOIL PACKET WITH THE CATHETER INSERTION KIT BREAKS THE STERILE TECHNIQUE OF PREPARING FOR STERILE INTERMITTENT CATHETERIZATION. I WILL PAINT YOU THE PICTURE. THE STERILE CATHETER INSERTION KIT CONTAINS A CSR WRAP (WATER PROOF PAD FOR A STERILE WORK AREA), GLOVES, A POVIDONE IODINE PREP PAD INSIDE SEALED FOIL, AND A BENZALKONIUM CHLORIDE PREP PAD INSIDE SEALED FOIL. ALL OF THESE ARE PUT INTO A SEALED PACKAGE AND STERILIZED WITH ETHYLENE OXIDE GAS. THE KIT STATED, "THIS PRODUCT CONTAINS ETHYLENE OXIDE, A CHEMICAL KNOWN TO (B)(6) TO CAUSE CANCER, OR BIRTH DEFECTS, OR OTHER REPRODUCTIVE HARM." THE PROCEDURE REQUIRES OPENING THE SEALED PACKAGE, PUTTING THE WRAP UNDER THE WORK AREA. (SMALL TABLE OR WHEN TRAVELING, MY LAP), PUTTING ON STERILE GLOVES, OPENING THE SEALED FOIL PACKET WITH THE POVIDONE IODINE PREP PAD AND THE SEALED FOIL PACKET WITH THE BENZALKONIUM CHLORIDE PREP PAD, CLEANSING MY URETHRAL AREA WITH STERILE GLOVES ON, THEN WITH MY RIGHT HAND, I INSERT THE STERILE CATHETER INTO MY BLADDER, USING MY LEFT GLOVED FORE AND MID FINGERS AS A GUIDE. THE VENDOR HAS PROVIDED THE PREP PADS, EACH IN BOXES OF APPROX 50 FOIL PACKETS. THE OUTSIDE OF THE FOIL PACKETS ARE NOT STERILE. IF I WERE TO USE THE REPLACEMENT PACKETS, I WOULD BREAK THE STERILE PROCEDURE BECAUSE TO OPEN THE PAD PACKETS BEFORE I PUT ON STERILE GLOVES WOULD CONTAMINATE THE PADS BECAUSE THE 2X2FL SIZE PACKET PROHIBITS OPENING AT ONE END AND PEELING THE PACKET APART TO DROP ONTO THE STERILE WORK AREA. THE OTHER OPTION WOULD BE TO OPEN THE PACKETS WITH STERILE GLOVES ON, BUT, THAT WOULD CONTAMINATE THE GLOVES AND CONTAMINATE THE REMAINDER OF THE PROCEDURE. I HAVE AT LEAST 1000 STERILE CATHETER INSERTION KITS (MOST OF WHICH WERE PURCHASED WITH MY OWN MONEY) THAT CONTAIN THE RECALLED POVIDONE IODINE PREP PADS. TO DATE, EVEN THOUGH I'VE EXPLAINED THE REQUIRED STERILE PROCEDURE TO THEM, MY VENDOR REFUSES TO REPLACE THE ENTIRE STERILE CATHETER INSERTION KITS BECAUSE "THERE ARE TOO MANY TO REPLACE." I HAVE "CHEMOTHERAPY INDUCED IMMUNOGLOBULINEMIA" AND MAINTAINING STERILE TECHNIQUE OF INTERMITTENT CATHETERIZATION IS IMPERATIVE. THE RECALL WAS PRIOR TO (B)(6) 2011, AND TO DATE I HAVE NO SATISFACTORY REPLACEMENT. THERE IS ANOTHER PRODUCT THAT SHOULD BE RECALLED. TRIAD ALSO MADE THE BENZALKONIUM CHLORIDE PREP PAD THAT COMES IN THE STERILE CATHETER INSERTION KITS. APPROX A MONTH PRIOR TO FDA'S RECALL OF THE POVIDONE IODINE PREP PAD, THE FDA RECALLED TRIAD'S ALCOHOL PREP PADS BECAUSE THE PAD MATERIAL WAS "CONTAMINATED." I FEEL THAT THE RECALL SHOULD EXTEND TO TRIAD'S BENZALKONIUM CHLORIDE PREP PAD AS IT IS MADE FROM THE SAME MATERIAL AS THE ALCOHOL PREP PADS AND THE POVIDONE IODINE PREP PADS. (B)(4), SOLD TO (B)(4) WHO SOLD KITS TO (B)(4) MEDICAL SUPPLIES WHO SOLD THE PRODUCT TO ME. DATE OF USE: (B)(6) 2010 - (B)(6) 2011.