ORAL EZE ORAL FLUID COLLECTION SYSTEM
Received Sep 24, 2020 · Event occurred Aug 18, 2020
Report 3010939897-2020-00001 · MDR key 10580917
Device
Generic name
Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
Manufacturer
Microgenics CorporationModel number
96100Catalog number
96100
Product problems
- Device Handling Problem
- Device Handling Problem
Patient
Not reported
- Chemical Exposure
- Chemical Exposure
Narrative
Additional Manufacturer Narrative
EMERGENCY MEDICAL PERSONNEL WERE CALLED, INCLUDING AMBULANCE AND FIRE, ALONGSIDE CONSULTING WITH THE CDC. EMS TOOK PATIENT'S VITALS AND TALKED WITH HIM ABOUT HIS EXPOSURE TO THE SODIUM AZIDE SOLUTION. PATIENT WAS CLEARED TO SAFELY LEAVE. WHILE SODIUM AZIDE IS A HIGHLY TOXIC SUBSTANCE, THE AMOUNT AVAILABLE IN THE PRODUCT IS CAPABLE OF CAUSING HYPOTENSION, OR OTHER MILD AND REVERSIBLE SYMPTOMS SUCH AS DIZZINESS, MENTAL STATUS CHANGES.
Description of Event or Problem
SAMPLE DONOR RE-INSERTED THE COTTON SWAB OF HIS COMPLETED DRUG TEST INTO HIS MOUTH AFTER HAVING IMMERSED THE SWAB IN THE 0.09% SODIUM AZIDE PRESERVATION SOLUTION WITHIN THE ORAL-FLUID COLLECTION TUBE.