Description of Event or Problem · 1
IN THE SPRING OF 1999 MEDICAL CTR BEGAN USING BECTON DICKINSON PRODUCT #365974 MICROCOLLECTION TUBES. THE CHANGE WAS MADE BECAUSE THE PREVIOUS PRODUCT #365973 WAS BEING REPLACED BY THE "NEW IMPROVED" MICROCOLLECTION TUBE. SINCE IMPLEMENTATION OF PRODUCT #365974 USER FACILITY HAS EXPERIENCED AN INORDINATE NUMBER OF BABY/INFANT REDRAWS FROM APRIL THROUGH DEC, 1999. ERRONEOUSLY LOW PLATELET COUNTS WERE ENCOUNTERED UPON MICROCLOT FORMATION AS WELL AS FIBRIN CLOTS FORMING PRIOR TO INSTRUMENT ASPIRATION. PEDIATRICIANS AND FAMILY MEMBERS WERE UPSET AT THE FREQUENCY OF INFANT REDRAWS. ALL PHLEBOTOMY STAFF MEMBERS WERE RE-TRAINED IN INFANT/MICROCOLLECTION TECHNIQUES BY THE BD SALESPERSON. IN ADDITION, QUIKHEEL LANCETS WERE PURCHASED TO ENHANCE BLOOD FLOW. FACILITY CONTACTED THE BD TECHNICAL SVS DEPT MANY TIMES AND WAS TOLD IT WAS FACILITY'S PROBLEM RATHER THAN A SPECIMEN INTEGRITY. FACILITY HAS RECENTLY LEARNED THAT BD HAS RESUMED PRODUCTION OF THE ORIGINAL PRODUCT (#365973). FACILITY SWITCHED BACK TO THAT PRODUCT AND HAS HAD EXCELLENT RESULTS. BD CONTINUES TO INSIST THAT THERE IS NO PROBLEM WITH THE NEW PRODUCT DESPITE THEIR RESUMPTION OF PRODUCTION OF THE OLD PRODUCT. IN ADDITION, THEY REFUSE TO TAKE BACK OR REPLACE THE NEW PRODUCT. FACILITY'S OPINION IS THAT PRODUCT #365974 IS DEFECTIVE AND REPRESENTS A RISK TO THE PT'S WELL BEING. IT IS ALSO FACILITY'S OPINION THAT THIS PRODUCT NEEDS TO BE MODIFIED OR REMOVED FROM THE MARKET.