BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B, 30 TESTS

Additional Manufacturer Narrative

A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B, 30 TESTS REAGENT SPRAYED USER IN THE FACE. CUSTOMER STATED THE PLASTIC VIAL IS NOT SOFT AND REQUIRED PRESSURE BE APPLIED TO THE VIAL IN ORDER TO PLACE 3 DROPS ON THE REAGENT CARTRIDGE. WHEN PRESSURE WAS APPLIED THE TOP OF THE VIAL POPPED OFF. THE SPRAYING HAS OCCURRED TWO TIMES, ONCE ON A LAB COAT AND FACE, AND ONCE ON THE COUNTER. INITIALLY IT WAS REPORTED THAT THE TUBE CONTAINED NO PATIENT SAMPLE. AFTER ADDITIONAL FOLLOW-UP IT WAS CONFIRMED THE VIAL CONTAINED PATIENT SPECIMEN. THE CUSTOMER WAS NOT WEARING GOGGLES. THE CUSTOMER DID NOT SEE A PHYSICIAN FOR THE INCIDENT, BUT WIPED COUNTER WITH GERMICIDAL WIPES, WASHED HANDS AFTER REMOVING GLOVES, AND WIPED FACE WITH TISSUE TO MINIMIZE EXPOSURE.