BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUREPATH COLLECTION VIAL

    MDR report key: 865890 · Received June 14, 2007

    Report

    Report Number
    1062336-2007-00002
    Event Type
    Other
    Date Received
    June 14, 2007
    Date of Event
    May 15, 2007
    Report Date
    June 14, 2007
    Manufacturer
    TRIPATH IMAGING, INC.
    Product Code
    LEA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WAS CLEARLY AN UNUSUAL ACCIDENT AND USER ERROR; THERE WAS NO DEVICE MALFUNCTION. DECISION TO FILE WAS BASED ON THE FACT THAT THE PT SOUGHT MEDICAL HELP AS A RESULT OF USING THE DEVICE.

    Description of Event or Problem · 1

    IN 2007, TRIPATH IMAGING REC'D A REPORT FROM A OB/GYN CLINIC, THAT WHILE A PT WAS IN THE OFFICE, SHE MISTAKENLY DRANK A 10ML VIAL CONTAINING SUREPATH PRESERVATIVE FLUID. THAT FLUID CONTAINS MOSTLY ETHANOL BUT ALSO 120 MICROLITERS OF METHANOL (1.2%). THE VIAL IS USED TO PRESERVE A CERVICAL CYTOLOGY SAMPLE FOR ANALYSIS. THE PT CLEARLY MISUNDERSTOOD THE NURSE'S INSTRUCTIONS. PT WAS SENT TO AN ER FOR EVAL AND POISON CONTROL WAS CALLED. PT WAS GIVEN FLUIDS AND RELEASED THE SAME DAY. SHE IS APPARENTLY FINE WITH NO SIDE EFFECTS. NO MALFUNCTION, USER ERROR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other