BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREPATH® PRESERVATIVE FLUID COLLECTION VIAL

    MDR report key: 5686015 · Received May 27, 2016

    Report

    Report Number
    1062336-2016-00001
    Event Type
    Injury
    Date Received
    May 27, 2016
    Date of Event
    April 14, 2016
    Report Date
    May 27, 2016
    Manufacturer
    TRIPATH IMAGING, INC.
    Product Code
    LEA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    SUREPATH® PRESERVATIVE FLUID IS DESIGNED FOR USE WITH THE PREPSTAIN® SYSTEM. SUREPATH® PRESERVATIVE FLUID IS AN ALCOHOL-BASED, PRESERVATION SOLUTION THAT SERVES AS A TRANSPORT, PRESERVATIVE AND ANTIBACTERIAL MEDIUM FOR GYNECOLOGIC SPECIMENS. BD QUALITY HAS INVESTIGATED THE COMPLIANT OF PAP RESULT REVIEW WITH PRODUCT 490527 SUREPATH® PRESERVATIVE FLUID COLLECTION VIAL. QUALITY PERFORMED A PRODUCT NONCONFORMANCE REVIEW AND DETERMINED THAT ALL PRODUCTS WERE WITHIN SPECIFICATIONS. A COMPLAINT HISTORY REVIEW FOUND ZERO (0) PREVIOUS REPORTS FOR FALSE NEGATIVES RELATED TO SUREPATH® PRESERVATIVE FLUID COLLECTION VIAL. NO RETURN MATERIALS WERE RECEIVED FROM THE CUSTOMER. AN ADDITIONAL REVIEW OF THE SLIDES BY CYTOLOGISTS AND PATHOLOGISTS AT THE CUSTOMER SITE CONFIRMED THAT THE SLIDES WERE NEGATIVE. THIS COMPLAINT IS NOT CONFIRMED. QUALITY WILL CONTINUE TO TRACK AND MONITOR FOR TRENDS. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    LABORATORY REPORTED A PATIENT DIAGNOSED WITH POORLY DIFFERENTIATED SQUAMOUS CELL CARCINOMA IN (B)(6) 2016. THE LAB REPORTS THAT THE PATIENT HAD HAD FOUR PAP TESTS OVER THE LAST FIVE YEARS (LAST DATED (B)(6) 2015) THAT WERE ALL NEGATIVE. FIVE-YEAR REVIEW OF PATIENT'S PAP SMEARS WAS PERFORMED BY TWO CYTOTECHNOLOGISTS AND THREE PATHOLOGISTS AND ALL CONFIRMED THAT ALL THE SLIDES WERE CORRECTLY IDENTIFIED AS NEGATIVE. ON (B)(6) 2016, PATIENT'S GENERAL PRACTITIONER ORDERED AN ULTRASOUND WHEN PATIENT REPORTED BLOATING AND IRREGULAR PERIODS. ULTRASOUND REVEALED A TUMOR AND A BIOPSY WAS ORDERED WHICH IDENTIFIED THE CARCINOMA. PATIENT WAS SENT TO ONCOLOGY AND STARTED ON PALLIATIVE CARE AND CHEMOTHERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341189 SUREPATH® PRESERVATIVE FLUID COLLECTION VIAL PRESERVATIVE, CYTOLOGICAL LEA TRIPATH IMAGING, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening