BD BBL PORT-A-CUL ENVELOPE

Description of Event or Problem

THE MICROBIOLOGY LAB HAD FOLLOWED UP ON A CONFUSING ARTIFACT SEEN IN THE BECTON DICKINSON (BD) BBL PORT-A-CUL ANAEROBIC TRANSPORT MEDIA. IT LOOKED LIKE A GRAM VARIABLE ROD BUT WAS NON-VIABLE. AT THE TIME DECISION WAS MADE TO IN-SERVICE THE LAB STAFF TO RECOGNIZE THE ARTIFACT SO IT WOULD NOT BE REPORTED AS AN ORGANISM. SINCE THE ORGANISM WAS NON-VIABLE, AND THERE WAS NO DANGER OF THE LAB WORKING IT UP ON THE CULTURE, THE DECISION MADE TO EDUCATE STAFF NOT TO REPORT THESE ARTIFACTS ON THE GRAM STAIN WE COULD CONTINUE TO USE THEM UNTIL A REPLACEMENT PRODUCT WAS FOUND. IN-SERVICING AND RELATED E-MAIL TOOK PLACE BUT THE EDUCATION PROCESS FAILED AS A RESULT OF THE SURGERY AND THE REPORT OF RARE GRAM NEG RODS. A SURGERY TOOK PLACE AND A STAT GRAM NEG SPECIMEN SENT TO THE LAB. THE RESULTS WERE INCONCLUSIVE. FINDINGS WERE OF RARE GRAM NEGATIVE RODS. A TISSUE SAMPLE WAS THEN SENT RATHER THAN SWAB. THE CULTURE MEDIUM WAS CULTURED AND GRAM NEGATIVE RODS WERE FOUND.THE LAB CONTACTED BD TECHNICAL SERVICE AND INFORMED THE PACKAGE INSERT FOR THE PRODUCT STATES: TRANSPORT MEDIA SOMETIMES CONTAIN DEAD ORGANISMS VISIBLE UPON GRAM STAINING. SCRIPPS HAS REQUESTED AN INTERNAL RECALL OF THIS PRODUCT AND REMOVE IT FROM ALL SITES.======================MANUFACTURER RESPONSE FOR ANAEROBIC TRANSPORT MEDIA, BD BBL PORT-A-CUL ENVELOPE (PER SITE REPORTER).======================INSTRUCTED TO REVIEW PACKAGE INSERT.