BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUREPATH PRESERVATION FLUID

    MDR report key: 1508083 · Received October 9, 2009

    Report

    Report Number
    1062336-2009-00003
    Event Type
    Other
    Date Received
    October 9, 2009
    Date of Event
    September 17, 2009
    Report Date
    October 9, 2009
    Manufacturer
    TRIPATH IMAGING, INC.
    Product Code
    MKQ
    PMA / PMN Number
    P970018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS AN ACCIDENTAL SPLASH UNRELATED TO THE DESIGN OR FUNCTION OF THE DEVICE. THE SUREPATH PRESERVATIVE FLUID PACKAGE INSERT CONTAINS THE FOLLOWING WARNING, "AVOID SPLASHING OR GENERATING AEROSOLS. OPERATORS SHOULD WEAR USE APPROPRIATE HAND, EYE AND CLOTHING PROTECTION." IT IS NOT KNOWN IF THE PERSONNEL INVOLVED IN THE INCIDENT WAS WEARING PROTECTIVE EYEWEAR. THE CUSTOMER WAS NOT ABLE TO PROVIDE ANY INFORMATION REGARDING PRODUCT LOT NUMBER OR EXPIRATION DATE. NO SAMPLES WERE AVAILABLE FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

    AN EXPERIENCED PREPARATION TECHNOLOGIST WAS PLACING THE TUBE RACKS INTO THE CENTRIFUGE FOR THE SECONDS SPIN WHEN SHE SPLASHED A DROPLET FROM ONE OF THE SAMPLES INTO HER EYE. THEY WERE NOT ABLE TO DETERMINE FROM WHICH SAMPLE THE DROPLET CAME. THE TECHNICIAN IMMEDIATELY RINSED THE EYE WITH WATER FOR 15 MINUTES. ALTHOUGH SHE DID NOT HAVE ANY PAIN OR DISCOMFORT, THE TECHNICIAN LATER VISITED A DOCTOR TO MAKE SURE THERE WAS NO INJURY OR FURTHER TREATMENT REQUIRED. THE DOCTOR DID NOT RECOMMEND PROPHYLACTIC TREATMENT, NOR DID HE REPORT INJURY TO THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREPATH PRESERVATION FLUID CERVICAL CYTOLOGY COLLECTION MKQ TRIPATH IMAGING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention