BEUDAMED
    FDA Adverse Event Other Summary report: N

    PAP - PERFECT PLASTIC SPATULA

    MDR report key: 978058 · Received January 9, 2008

    Report

    Report Number
    1062336-2008-00001
    Event Type
    Other
    Date Received
    January 9, 2008
    Date of Event
    November 15, 2007
    Report Date
    January 9, 2008
    Manufacturer
    COOPERSURGICAL
    Product Code
    MKQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION IS A SIMPLE PLASTIC CERVICAL SCRAPING DEVICE THAT IS USED TO COLLECT A SAMPLE FROM PTS. FOLLOWING COLLECTION OF THE SAMPLE, THE TIP OF THE DEVICE IS BROKEN OFF INTO A COLLECTION VIAL CONTAINING PRESERVATIVE FLUID FOR SUBSEQUENT ANALYSIS. THE DEVICE IS LABELED TO WARN AGAINST USE WITHOUT PROPER PRECAUTIONS INCLUDING PROTECTIVE WEAR AND WARNINGS TO AVOID CREATING AEROSOLS OF THE SAMPLE. COOPERSURGICAL IS THE MFR OF THE DEVICE FOR BD-DIAGNOSTICS, TRIPATH. THE SPATULA PACKAGING IS LABELED WITH TRIPATH'S NAME AND LOGO AS WELL AS WITH THE MFR'S.

    Description of Event or Problem · 1

    IN 2007, A NURSE AT A PHYSICIAN'S OFFICE WAS HANDLING A PT CERVICAL CYTOLOGY SAMPLE AND ACCIDENTALLY SPLASHED THE SAMPLE INTO HER EYE WHILE TRYING TO REMOVE THE HEAD OF THE COLLECTION DEVICE. THE PERSON REPORTING THE EVENT STATED THAT INSTRUCTIONS FOR COLLECTING THE SAMPLE WERE FOLLOWED, AND THAT IT WAS "DIFFICULT" TO REMOVE THE HEAD OF THE COLLECTION DEVICE. WHEN THE HEAD EVENTUALLY SNAPPED A DROP OF THE SAMPLE SPLASHED INTO HER EYE. IT'S NOT KNOWN IF THE NURSE WAS WEARING RECOMMENDED PERSONAL PROTECTIVE EQUIPMENT. THE SAMPLE WAS NOT KNOWN TO BE POSITIVE FOR ANY INFECTION AGENT AND THE NURSE DID NOT SEEK TREATMENT FOR THE EXPOSURE. THE EVENT WAS NOT REPORTED TO BD-DIAGNOSTICS, TRIPATH UNTIL THE FOLLOWING MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAP - PERFECT PLASTIC SPATULA CERVICAL CYTOLOGY COLLECTION DEVICE MKQ COOPERSURGICAL PAPPERFECT SPATULA 57148

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention