A CUSTOMER IN THE UNITED STATES CONTACTED BIOM?RIEUX TO REPORT A BLOOD SAMPLE EXPOSURE IN ASSOCIATION WITH A BLOOD CULTURE KIT STANDARD. THE CUSTOMER REPORTED A NURSE WAS DRAWING BLOOD FROM A PATIENT, WITH A HISTORY OF FEVERS AND (B)(6) STATUS, INTO A BLOOD CULTURE BOTTLE WHEN THE VACUTAINER NEEDLE SLIPPED THROUGH THE RUBBER HUB. BLOOD DRIPPED PROFUSELY THROUGH THE NEEDLE. THE NURSE WAS ABLE TO REMOVE THE IV ACCESS THAT WAS CONNECTED TO THE VACUTAINER BUT SOME BLOOD SPILLED ON THE FLOOR AND THE NURSE'S SHOES AND PANTS. THE NURSE REFUSED TO BE SEEN AND DENIED TRANSMISSION OF BLOOD INTO HER EYES, MUCOUS MEMBRANE OR NON-INTACT SKIN. THE CUSTOMER CONFIRMED THE NEEDLE AS BEING BENT AND DID NOT SEPARATE FROM THE TOP OF THE HUB. IN ADDITION, THE BUTTERFLY DID NOT SEPARATE FROM THE LUER CONNECTION AT THE TOP OF THE HUB. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER TO BIOM?RIEUX THAT THIS ERROR LED TO ANY ADVERSE EVENT RELATED TO THE NURSE OR PATIENT'S STATE OF HEALTH. AN INTERNAL INVESTIGATION HAS BEEN INITIATED.
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Patient 1
A CUSTOMER IN THE UNITED STATES CONTACTED BIOM?RIEUX TO REPORT A BLOOD SAMPLE EXPOSURE IN ASSOCIATION WITH A BLOOD CULTURE KIT STANDARD. THE EVENT DID NOT IMPACT OR CAUSE HARM TO THE PATIENT OR CUSTOMER AS THE BOTTLE WAS SUCCESSFULLY INOCULATED AND THE CUSTOMER DENIES TRANSMISSION OF BLOOD INTO HER EYES, MUCOUS MEMBRANE OR NON-INTACT SKIN. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED. AN INVESTIGATION WAS CONDUCTED. THE ROOT CAUSE COULD NOT BE CONFIRMED BASED ON ALL AVAILABLE INFORMATION. HOWEVER, THE MOST PROBABLE ROOT CAUSE WAS DETERMINED TO BE PLACING A SMALLER DIAMETER VACUUM TUBE INTO THE HOLDER AT AN ANGLE THAT DAMAGED THE RUBBER BOOT COVERING THE NEEDLE. WHEN USING VACUUM TUBES WITH SMALL DIAMETERS USE OF AN ADAPTER OF APPROPRIATE SIZE IS RECOMMENDED. CAUTION SHOULD BE EXERCISED TO ENSURE THAT THE STOPPER IS PUNCTURED CENTRALLY AND THAT THE TUBES ARE NOT PLACED INTO THE HOLDER AT AN ANGLE. MISHANDLING OF THE DEVICE MAY RESULT IN A CONTAMINATED NEEDLE STICK , WHICH MAY LEAD TO TRANSMISSION OF INFECTIOUS DISEASES. THE PROCESS OF INJECTING A SPECIMEN INTO CULTURE BOTTLES OR VACUUM TUBES WHILE THE STOPPER IS IN PLACE IS NOT RECOMMENDED. THIS CAN CREATE POSITIVE PRESSURE AND RESULT IN SPECIMEN SPLATTERING FROM THE TUBE WHICH MAY CAUSE EXPOSURE TO BLOOD BORNE PATHOGENS, WHICH MAY CAUSE INFECTIOUS DISEASE. ANY ATTEMPT TO RE-PROCESS THE SAF-T HOLDER? FOR SUBSEQUENT RE-USE MAY ADVERSELY AFFECT THE INTEGRITY OF THE SAF-T HOLDER? IN PERFORMANCE. THE MANUFACTURER REPORTED NO IRREGULARITIES WERE IDENTIFIED DURING THE PRODUCTION PROCESS. THE BLOOD CULTURE KIT AND SAF-T HOLDE?R INSTRUCTION FOR USE WERE REVIEWED AND DETERMINED TO PROVIDE SUFFICIENT CAUTION AND INSTRUCTION TO THE USER ON PROPER HANDLING TECHNIQUE. GREAT CARE MUST BE TAKEN TO PREVENT SAMPLE EXPOSURE DURING INOCULATION INTO THE CULTURE BOTTLES AND VACUTAINERS.