BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCURUN 1 MULTI-MARKER POSITIVE CONTROL

    MDR report key: 724510 · Received June 9, 2006

    Report

    Report Number
    1220394-2006-00002
    Event Type
    Other
    Date Received
    June 9, 2006
    Date of Event
    May 19, 2006
    Report Date
    June 9, 2006
    Manufacturer
    BBI DIAGNOSTICS
    Product Code
    MJX
    PMA / PMN Number
    BK930027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE PRODUCT WAS TRANSFERRED FROM ITS ORIGINAL CONTAINER BY THE LAB, NO REQUEST WAS MADE FOR RETURN OF THE PRODUCT. THE PRODUCT IS SUPPLIED BY THE MFR IN A VIAL WITH A SCREW CAP CLOSURE. THE LAB ROUTINELY ALIQUOTS THE PRODUCT FROM ITS ORIGINAL CONTAINER TO A BULLET TOP TUBE WITH A SNAP TOP CLOSURE. THE PRODUCT LABELING INCLUDES A SAFETY PRECAUTION STATEMENT TO USE UNIVERSAL PRECAUTIONS WHEN HANDLING THE PRODUCT.

    Description of Event or Problem · 1

    TECHNOLOGIST REPORTED EYE SPLASH WITH PRODUCT. SHE EXPERIENCED DIFFICULTY SNAPPING OPEN THE BULLET TOP TUBE (THE PRODUCT IS MANUFACTURED AND SHIPPED IN A SCREW TOPPED CONTAINER, BUT THE LABORATORY ALIQUOTS THE PRODUCT OUT OF THIS ORIGINAL CONTAINER INTO BULLET TOP TUBES). WHEN SHE APPLIED FORCE TO SNAP OPEN THE CAP, UPON OPENING, DROPLETS OF THE PRODUCT SPLASHED INTO HER RIGHT EYE. TECHNOLOGIST WAS NOT WEARING PROTECTIVE EYEWEAR. SHE FLUSHED HER EYE WITH WATER FROM THE LABORATORY EYEWASH STATION. TECHNOLOGIST SOUGHT MEDICAL EVALUATION, AS THE PRODUCT CONTAINS CHEMICALLY TREATED HIV AND HEPATITIS POSITIVE RAW MATERIALS. AS A PRECAUTION, THE TECHNOLOGIST RECEIVED ANTI-HIV PROPHYLAXIS. NO HEPATITIS VACCINE WAS ADMINISTERED AS SHE HAD ALREADY BEEN IMMUNIZED AGAINST HEPATITIS B.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUN 1 MULTI-MARKER POSITIVE CONTROL 82MYZ MJX BBI DIAGNOSTICS SERIES 6000 108904

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other