AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT

Additional Manufacturer Narrative

THE AFFIRM ATTS COLLECTION KIT IS USED TO STABILIZE THE NUCLEIC ACID OF CANDIDA SPECIES, GARDNERELLA VAGINALIS, AND TRICHOMONAS VAGINALIS DURING SPECIMEN TRANSPORT AT AMBIENT TEMPERATURE (15-30 DEGREES C) OR (2-8 DEGREES C) FOR UP TO 72 HOURS. THE AFFIRM ATTS PACKAGE INSERT INDICATES THE PRODUCT IS TOXIC, HIGHLY FLAMMABLE, AND IS IRRITATING TO EYES, RESPIRATORY SYSTEM AND SKIN. IT INSTRUCTS USERS TO USE THE PRODUCT IN A WELL-VENTILATED AREA AND TO WEAR PROTECTIVE CLOTHING AND GLOVES. IF INHALED, THE PACKAGE INSERT INDICATES TO SUPPLY FRESH AIR OR OXYGEN, TO CONSULT THE MATERIAL SAFETY DATA SHEET (MSDS) AND TO SEE MEDICAL ADVICE. THE MSDS INDICATES THAT THIS PRODUCT HAS A HEALTH RATING OF 2 AND IS TOXIC BY INHALATION, IN CONTACT WITH SKIN AND IF SWALLOWED. THE PRODUCT CONTAINS DIMETHYLSULFOXIDE (DMSO) WHICH IS A KNOWN LUNG IRRITANT. THE FIRST AID SECTION OF THE MSDS PROVIDES THE FOLLOWING INSTRUCTIONS: "AFTER INHALATION SUPPLY FRESH AIR OR OXYGEN; AND IMMEDIATELY CALL FOR A DOCTOR." BD QUALITY COMPLETED A REVIEW OF PAST COMPLAINTS FOR THIS PRODUCT AND FOUND NO TREND FOR THIS ISSUE. BD QUALITY WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS TYPE OF ISSUE.

Description of Event or Problem

AN EMPLOYEE AT THE (B)(6) WAS HANDLING THE AFFIRM ATTS PRODUCT AND ACCIDENTLY INHALED IT. THE EMPLOYEE WAS HOLDING THE ATTS AMPULE UP IN THE AIR, LEVEL WITH HER FACE AND FAIRLY CLOSE TO NOSE AND SHE WAS ADDING THE LIQUID PRESERVATIVE TO THE COLLECTION TUBE. SHE WAS HANDLING THE PRODUCT BEDSIDE IN THE EXAM ROOM. SHE WAS NOT WEARING SAFETY GLASSES NOR WAS SHE WORKING UNDER A HOOD AT THE TIME OF THE EVENT. THE TECH IMMEDIATELY NOTED A METALLIC TASTE IN HER MOUTH. WITHIN A TIME FRAME OF 12-24 HOURS POST EXPOSURE, THE TECH BEGAN TO EXPERIENCE CHEST PAINS. SHE WENT TO THE ER WHERE CARDIAC ISSUES WERE RULED OUT. A CHEST X-RAY WAS PERFORMED AND THAT WAS NEGATIVE. TWO DAYS AFTER THE TECH VISITED THE ER, SHE WAS STILL EXPERIENCING DISCOMFORT IN HER CHEST. SHE VISITED AN URGENT CARE CENTER. SHE WAS DIAGNOSED WITH PLEURISY AND WAS SUBSEQUENTLY TREATED WITH ORAL STEROIDS AND PAIN MEDICATION. THE OCCUPATIONAL HEALTH NURSE HAS ALSO REPORTED THAT SINCE TREATMENT THE EMPLOYEE IS FEELING BETTER.