BD PROBETEC ET CT/GC AMPLIFIED DNA ASSAY COL

Description of Event or Problem

WHILE CALLING TO REPORT ANOTHER ISSUE, THE CUSTOMER INFORMED BD THAT THEY HAD EXPERIENCED AN INCIDENT IN 2008. AT THAT TIME, THEY HAD A CAP THAT FLEW OFF OF THE LYSED SAMPLE TUBE WHEN THEY WERE REMOVING THE RACK FROM THE LYSING HEATER. THE CAP AND ASSOCIATED SAMPLE HIT THE TECH IN THE EYE. THE TECHNICIAN WAS NOT WEARING SAFETY GLASSES. THE TECH USED TWO BOTTLES OF EYE WASH TO RINSE THE EYE BUT STILL FELT DISCOMFORT. SHE WENT TO THE ER AND WAS SEEN BY AN OPHTHALMOLOGIST. SHE WAS DIAGNOSED WITH A CORNEAL BURN AND GIVEN ANTIBIOTICS, GENTEAL EYEDROPS AND AN EYE PATCH. PATCH WAS WORN FOR 2-3 DAYS. SHE WENT BACK FOR FOLLOW UP WITHIN ABOUT A WEEK AND THE BURN WAS HEALED.

Additional Manufacturer Narrative

THIS PRODUCT IS PACKAGED AS A COLLECTION SET. THE SET INCLUDES A CLEANING SWAB, A COLLECTION SWAB AND A SAMPLE DILUENT VIAL. THE SAMPLE VIAL IS SENT TO LAB TO BE PROCESSED AND IS HEATED TO 112-116 DEGREES CELSIUS IN THE LYSING HEATER. ONCE THE SAMPLES ARE ALLOWED TO COOL FOR A PERIOD OF TIME, THE SAMPLE SWAB IS REMOVED FROM THE DILUENT AND THE DILUENT VIAL IS FURTHER PROCESSED. THE CUSTOMER COULD NOT SUPPLY THE LOT NUMBER OF THE VIAL THAT WAS INVOLVED IN THE INCIDENT. BD IS UNABLE TO FURTHER INVESTIGATE A SPECIFIC LOT NUMBER. THIS TYPE OF INCIDENT HAS NEVER BEEN REPORTED IN THE HISTORY OF THE DEVICE. THE DEVICE WAS RELEASED FOR SALE IN 1999. ALTHOUGH BD WAS UNABLE TO CONFIRM THE ISSUE, WE WILL CONTINUE TO TREND AND INVESTIGATE THIS TYPE OF DEFECT.