BEUDAMED
    FDA Adverse Event Other Summary report: N

    PAPPERFECT PLASTIC SPATULA

    MDR report key: 734871 · Received July 14, 2006

    Report

    Report Number
    1062336-2006-00002
    Event Type
    Other
    Date Received
    July 14, 2006
    Date of Event
    June 8, 2006
    Report Date
    July 14, 2006
    Manufacturer
    MEDSCAND
    Product Code
    MKQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY WAS TRAINED ON THE PROPER USE OF THE CERVICAL SAMPLING DEVICE BY TRIPATH IMAGING, INC. THEY, IN TURN, TRAINED THEIR EMPLOYEES. 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 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 AEROSOLE OF THE SAMPLE. MEDSCAND IS THE MANUFACTURER OF THE DEVICE. THE SPATULA IS INCLUDED IN THE SUREPATH COLLECTION KIT.

    Description of Event or Problem · 1

    ON JUNE 19, 2006, A REPORT WAS RECEIVED THAT AN ACCIDENT OCCURRED WHILE A HEALTH CARE PROFESSIONAL WAS HANDLING A PATIENT CERVICAL CYTOLOGY SAMPLING DEVICE. DURING THE PROCEDURE, SHE PLACED THE DETACHABLE HEAD PORTION OF THE PAP PERFECT PLASTIC SPATULA INTO THE SUREPATH PRESERVATIVE FLUID COLLECTION VIAL. IN DOING SO, SOME OF THE COLLECTED CERVICAL CYTOLOGY SAMPLE SPLASHED INTO THE HELATH CARE PROFESSIONAL'S EYE. THE SAMPLE WAS FROM AN HIV POSITIVE PATIENT. THE CLINIC INITIATED THEIR INTERNAL PROCEDURE FOR BLOOD BOURNE PATHOGEN EXPOSURE. THE HEALTH CARE PROFESSIONAL IS RECEIVING MEDICAL TREATMENT. THE DETAILS OF THAT TREATMENT ARE UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAPPERFECT PLASTIC SPATULA CERVICAL CYTOLOGY COLLECTION DEVICE MKQ MEDSCAND PAPPERFECT SPATULA 49683

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other