ACCURUN 1 MULTI-MARKER POSITIVE CONTROL
Received Apr 28, 2006 · Event occurred Apr 11, 2006
Report 1220394-2006-00001 · MDR key 707895
Device
Generic name
82myz
Manufacturer
Bbi DiagnosticsModel number
SERIES 4400Catalog number
A001-4408-P
Lot number
109744
Product problems
- Difficult to Remove
Patient
29 YR
- Exposure to Body Fluids
Narrative
Description of Event or Problem
TECHNOLOGIST REPORT EYE SPLASH WITH PRODUCT. SHE EXPERIENCED DIFFICULTY REMOVING THE PUSH AND PULL CAP FROM A VIAL OF THE PRODUCT (THE PRODUCT IS MANUFACTURED AND SHIPPED WITH A SCREW CAP, BUT THE LABORATORY REPLACED THE SCREW CAP WITH A PUSH AND PULL CAP). WHEN SHE APPLIED FORCETO THE CAP, A DROP OF PRODUCT ON THE CAP SPLASHED INTO HER LEFT EYE. TECHNOLOGIST WAS NOT WEARING PROTECTIVE EYEWEAR AND WAS WEARING CONTACT LENSES. SHE REMOVED HER CONTACT LENS AND FLUSHED HER EYE WITH WATER FOR APPROXIMATELY 10 MINUTES. TECHNOLOGIST WAS REFERRED TO THE HOSPITAL'S OUTPAIENT INFECTIOUS DISEASE SERVICE FOR FOLLOW-UP MEDICAL EVALUATION, AS THE PRODUCT CONTAINS CHEMICALLY TREATED HIV AND HEPATITIS POSITIVE RAW MATERIALS. AS A PRECAUTION, THE TECHNOLOGIST RECEIVED ANTI-HIV PROHYLAXIS AND A HEPATITIS B VACCINE, ALTHOUGH THE RISK OF INFECTION WAS FELT TO BE LOW.