ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE
Received May 17, 2000 · Event occurred Feb 9, 2000
Report 3023752-2000-00005 · MDR key 278857
Device
Generic name
Oral Fluid Specimen Collection
Manufacturer
Epitope, Inc.Model number
503-0011Catalog number
NA
Lot number
UNK
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
UNKNOWN
- Exposure to Body Fluids
Narrative
Description of Event or Problem
THE COMPLAINANT, AN INSURANCE AGENT, REPORTED AN ACCIDENTAL EXPOSURE TO BODY FLUIDS AFTER COMPLETION OF AN ORAL FLUID COLLECTION USING AN ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE. PRIOR TO CONDUCTING AN ORAL FLUID COLLECTION FROM THE PROPOSED INSURED, THE COMPLAINANT FELL DOWN AND SUFFERED AN ABRASION BELOW THE LITTLE FINGER. THE COMPLAINANT REPORTS THAT THERE WAS SOME SLIGHTLY BROKEN SKIN AT THE ABRASION SITE. FOLLOWING ADMINISTRATION OF THE ORAL FLUID COLLECTION, THE COMPLAINANT CLEANED UP THE WRAPPERS, INSTRUCTIONS, AND THE DISCARDED STICK HANDLES OF THE DEVICE. WHILE CLEANING UP THESE ITEMS, THE COMPLAINANT'S LEFT HAND CAME INTO CONTACT WITH THE DISCARDED STICK OF THE PROPOSED INSURED. THE STICK WAS WET WITH WHAT THE COMPLAINANT PRESUMES TO BE THE PROPOSED INSURED'S SALIVA. THE STICK CAME INTO CONTACT WITH THE COMPLAINANT'S ABRASION AND BROKEN SKIN. THE COMPLAINANT WAITED TO WASH THE HANDS UNTIL CONPLAINANT ARRIVED AT HOME BECAUSE THE BATHROOM AT THE PROPOSED INSURED WAS OCCUPIED AT THE TIME OF THE ACCIDENTAL EXPOSURE. THE COMPLAINANT EXPRESSED CONCERN THAT COMPLAINANT HAD BEEN EXPOSED TO SOMETHING THROUGH CONTACT WITH THE DISCARDED STICK AND LATER LEARNED THAT THE PROPOSED INSURED HAD BEEN DENIED INSURANCE COVERAGE.