BEUDAMED
    FDA Adverse Event Other Summary report: N

    PAP-PERFECT PLASTIC SPATULA

    MDR report key: 1023761 · Received March 25, 2008

    Report

    Report Number
    1062336-2008-00004
    Event Type
    Other
    Date Received
    March 25, 2008
    Date of Event
    March 10, 2007
    Report Date
    March 25, 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 PATIENTS. FOLLOWING COLLECTION OF THE SAMPLE, THE HEAD OF THE DEVICE IS BROKEN OFF INTO A COLLECTION VIAL CONTAINING PRESERVATIVE FLUID FOR SUBSEQUENT ANALYSIS. THE SUREPATH PRESERVATIVE FLUID PACKAGE INSERT CONTAINS WARNINGS AGAINST USE WITHOUT PROPER PRECAUTIONS INCLUDING PROTECTIVE EYEWEAR AND WARNINGS TO AVOID CREATING AEROSOLS OF THE SAMPLE. REPRESENTATIVES TRAINED CLINIC PERSONNEL TO USE ONE OF TWO TECHNIQUES TO SNAP OFF THE DEVICE HEAD. IN THIS CASE THE CLINICS WERE NOT USING EITHER TECHNIQUE. REPRESENTATIVES HAVE RETRAINED CLINIC PERSONNEL TO HELP ELIMINATE THIS TYPE OF EXPOSURE. COOPERSURGICAL IS THE MANUFACTURER OF THE DEVICE. THE SPATULA IS PACKAGED WITH A CERVICAL BRUSH AND IS LABELED WITH THE DISTRIBUTOR'S NAME AND LOGO AS WELL AS WITH THE MANUFACTURER'S. ADD'L LOT# 57149.

    Description of Event or Problem · 1

    A FACILITY REPORTED TO THEIR CLINICAL LABORATORY SERVICES PROVIDER 3 INSTANCES OF CLINIC PERSONNEL BEING SPLASHED IN THE EYE WITH SUREPATH PRESERVATIVE FLUID WITH PAP SAMPLE. THE EVENTS OCCURRED IN 2008. IN EACH CASE, THE PRACTITIONER WAS ATTEMPTING TO REMOVE THE HEAD OF THE COLLECTION SPATULA WHEN THE SAMPLE WAS SPLASHED. THEY STATED THAT IT WAS "DIFFICULT" TO REMOVE THE HEAD OF THE COLLECTION DEVICE. CLINIC PERSONNEL WERE NOT WEARING RECOMMENDED PERSONAL PROTECTIVE EQUIPMENT. THE SAMPLES WERE NOT KNOWN TO BE POSITIVE FOR ANY INFECTIOUS AGENT, HOWEVER, ALL EXPOSED PERSONNEL WERE TREATED WITH PROPHYLAXIS MEDICATIONS AS A PRECAUTION AND WILL BE MONITORED FOR 3-6 MONTHS PER CLINIC POLICY.

    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