Description of Event or Problem · 1
A MEDICAL TECHNOLOGIST COMMENTED THAT HE HAS BEEN SEEING UNUSUAL GRAM NEGATIVE RODS APPEARING IN GRAM STAINS FROM PORT-A-CUL COLLECTION DEVICES. FOUR LOT NUMBERS WERE PULLED AND THE TRANSPORT MEDIUM FROM EACH WERE GRAM STAINED, VERIFYING THE PRESENCE OF THESE ORGANISMS. THE MFR WAS CONTACTED ON (B)(6) 2013, AT WHICH TIME A TECHNICAL SERVICE REP INDICATED THAT THIS IS NOTED ON THEIR PACKAGE INSERT. THE INSERT STATES AS A LIMITATION THAT "CAUTION SHOULD BE EXERCISED IN REPORTING DIRECT GRAM STAIN AND/OR OTHER DIRECT MICROBIOLOGICAL STAIN RESULTS ON SPECIMENS PROCESSED WITH THIS MEDIUM DUE TO THE POSSIBLE PRESENCE OF NONVIABLE ORGANISMS IN THE TRANSPORT MEDIUM." THESE WERE ENTERED INTO THE MFR'S ISIS SYSTEM AS CASE NUMBERS (B)(4), CORRESPONDING TO LOT NUMBERS 2308467, 2248221, 2275138 AND 2146311. THIS TRANSPORT SYSTEM IS USED FOR THE COLLECTION AND TRANSPORT OF BIOLOGICAL MATERIAL FOR ROUTINE CULTURE, TYPICALLY FROM WOUND, SURGICAL AND OTHERWISE STERILE SPECIMENS. BEING ACCREDITED BY (B)(6), THE LAB IS REQUIRED TO INCLUDE A DIRECT GRAM STAIN FROM ALL OF THESE SPECIMEN TYPES ON OUR CULTURE REPORTS. CONTINUED USE OF THIS PRODUCT MAY RESULT IN THE REPORTING OF FALSE POSITIVE GRAM STAIN RESULTS THAT WILL BE UNABLE TO BE CORRELATED BACK TO CULTURE. THE MFR, BECTON DICKINSON, HAS INDICATED THE IMPLEMENTATION OF A NEW FILTERING SYSTEM THIS YR THAT WILL "MINIMIZE" FUTURE INSTANCES. THIS, HOWEVER, WILL NOT ELIMINATE FUTURE OCCURRENCES OF NON-VIABLE MICROORGANISMS APPEARING ON THESE DIRECT SMEARS. THIS TRANSPORT SYSTEM IS USED BY ONE CLIENT WITHIN OUR SYSTEM, AND THE CLIENT WAS NOTIFIED TO DISCONTINUE USE OF THE TRANSPORT SYSTEM ON (B)(6) 2013.