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OtherMJX

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 Diagnostics

Model number

SERIES 4400

Catalog 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.