KIT, APTIMA CMB2 ASSAY
Received Sep 6, 2017 · Event occurred Aug 8, 2017
Report 2024800-2017-00020 · MDR key 6847142
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Irritation
- Chemical Exposure
- Irritation
- Chemical Exposure
Narrative
Description of Event or Problem
(B)(6) REPORTED THAT ONE OF THEIR OPERATORS ((B)(6)) HAD SPLASHED AUTO DETECT 1 (FROM BOTTLE A / PN: LR0167G-01) INTO HER EYES WHILE SHE WAS REMOVING THE QUICK DISCONNECT FITTING FROM THE AUTO DETECT 1A (AD1A) BOTTLE OF THE TIGRIS. THE OPERATOR WAS WEARING A FACE SHIELD WHEN INCIDENT HAPPENED BUT WAS CROUCHING CLOSE TO THE FLUID DRAWER SUCH THAT THE SPLASH WENT UNDERNEATH THE FACE SHIELD. THE OPERATOR IMMEDIATELY RINSED HER EYES FOR 15 MINUTES. THE OPERATOR FELT IRRITATION IN HER EYES AND WENT TO SEE A PHYSICIAN. THE PHYSICIAN TREATED HER AND SHE WAS GIVEN TWO DAYS OFF. THE OPERATOR WENT TO SEE A PHYSICIAN BUT WAS ABLE TO RETURN TO WORK AFTER TWO DAYS.