BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1062336-2016-00002

    MDR report key: 5686010 · Received May 27, 2016

    Report

    Report Number
    1062336-2016-00002
    Event Type
    Injury
    Date Received
    May 27, 2016
    Date of Event
    April 30, 2016
    Report Date
    May 27, 2016
    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

    PATIENT REPORTED WITH VISIBLE LESIONS BUT RECEIVED NEGATIVE PAP AND (B)(6) TEST RESULTS. A CERVICAL BIOPSY WAS PERFORMED RESULTING IN A DIAGNOSIS OF INVASIVE SQUAMOUS CELL CARCINOMA. A SECOND (B)(6) TEST WAS PERFORMED FOLLOWING THE BIOPSY AND WAS ALSO NEGATIVE. A REVIEW OF HER SLIDE BY MULTIPLE CYTOLOGISTS AND PATHOLOGISTS CONFIRMED IT AS NEGATIVE.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening