BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUREPATH COLLECTIONS VIAL

    MDR report key: 859466 · Received June 1, 2007

    Report

    Report Number
    1062336-2007-00001
    Event Type
    Other
    Date Received
    June 1, 2007
    Date of Event
    May 8, 2007
    Report Date
    May 31, 2007
    Manufacturer
    TRIPATH IMAGING, INC.
    Product Code
    LEA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A RESEARCHER AT UNIVERSITY WAS USING A SUREPATH COLLECTION VIAL OFF LABEL FOR A RESEARCH STUDY. THEY HAD OBTAINED THE VIALS FROM ANOTHER LAB AND WERE NOT TRAINED USERS ON THE SUREPATH PROCESS. NO OTHER SUREPATH OR PREPSTAIN DEVICE WAS INVOLVED IN THIS INCIDENT. THE RESEARCHER WAS PIPETTING SOME SAMPLE FROM THE VIAL INTO A TUBE WHEN SHE ACCIDENTLY CAUSED SOME RESIDUAL FLUID FROM THE PIPETTE TIP TO BE SPRAYED INTO HER UNPROTECTED EYE. THE AMOUNT WAS ONLY MICRO-DROPLETS. THE SAMPLE, HOWEVER, CONTAINED ALCOHOLS, FORMALDEHYDE AND HPV VIRUS. THE EYE WAS IRRIGATED WITH SALINE SOLUTION PER INSTRUCTIONS ON OUR LABELING BUT NOT OTHER MEDICAL ACTIONS ARE BEING TAKEN. THIS WAS CLEARLY AN ACCIDENT AND USER ERROR; THERE WAS NO DEVICE MALFUNCTION. DECISION TO FILE WAS BASED ON CO SOPS AND THE POSSIBILITY OF POTENTIAL PROBLEMS WITH THIS PT RELEVANT TO EITHER THE PRESERVATIVE SOLUTION OR THE HPV IN HER EYE.

    Description of Event or Problem · 1

    ON 05/08/07, TRIPATH IMAGING REC'D A REPORT FROM OUR DISTRIBUTOR THAT AN ACCIDENT OCCURRED WHILE A HEALTH CARE PROFESSIONAL WAS HANDLING A PT COLLECTION VIAL NORMALLY ASSOCIATED WITH SUREPATH/PREPSTAIN DEVICE. A TECHNICIAN IN THE LABORATORY AT UNIVERSITY REMOVED THE LID OF THE VIAL AND EXTRACTED 100 UL USING A PLASTIC PIPETTE. THE SAMPLE WAS TRANSFERRED IN THE FUME HOOD, BUT AS THE PIPETTE WAS BEING DISCARDED INTO THE WASTE BUCKET, THE PIPETTE TIP CAUGHT THE EDGE OF THE FUME HOOD CAUSING THE PIPETTE BUNDLE TO BEND AND SPRAY ITS RESIDUAL CONTENTS INTO THE TECHNICIAN'S EYE. SAFETY GOGGLES HAD NOT BEEN WORN. THE TECHNICIAN THEN WASHED HER EYE USING A SALINE EYEWASH AND HAS SUFFERED NO ILL EFFECTS. THE COLLECTION VIAL WAS THE ONLY COMPONENT INVOLVED; NO OTHER PART OF THE SUREPATH/PREPSTAIN DEVICE WAS USED IN THIS INCIDENT. THE PRESERVATIVE FLUID HAS BEEN SHOWN TO BE VIRICIDAL TO HIV, HBV AND HCV. HPV HAS NEVER BEEN TESTED IN THIS PRESERVATIVE FLUID BECAUSE IT CANNOT BE CULTURED. WE MAKE NO CLAIMS CONCERNING VIRUSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREPATH COLLECTIONS VIAL CERVICAL CYTOLOGY COLLECTION VIAL LEA TRIPATH IMAGING, INC. COLLECTION VIAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other