BEUDAMED
    FDA Adverse Event Other Summary report: N

    PAP-PERFECT PLASTIC SPATULA

    MDR report key: 1473417 · Received September 8, 2009

    Report

    Report Number
    1062336-2009-00002
    Event Type
    Other
    Date Received
    September 8, 2009
    Date of Event
    July 22, 2009
    Report Date
    September 8, 2009
    Manufacturer
    COOPERSURGICAL
    Product Code
    MKQ
    PMA / PMN Number
    P970018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION IS A SIMPLE PLASTIC CERVICAL SCRAPING DEVICE THAT IS USED TO COLLECT A PAP SAMPLE FROM PTS. 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. PERSONNEL AT THE SITE HAD BEEN TRAINED ON PROPER SAMPLE COLLECTION LESS THAN 2 MONTHS PRIOR TO THE INCIDENT. THE CLINICIAN THAT WAS SPLASHED IN THE EYE RECEIVED BASIC FIRST AID (RINSED EYE WITH WATER) AND DECLINED TO SEEK IMMEDIATE MEDICAL ATTENTION. SHE STATED THAT SHE WOULD F/U WITH HER PERSONAL PHYSICIAN. COOPERSURGICAL IS THE MFR OF THE DEVICE FOR BD-DIAGNOSTICS-TRIPATH. THE SPATULA IS PACKAGED WITH A CERVICAL BRUSH AND IS LABELED WITH THE TRIPATH IMAGING, INC. NAME AND LOGO AS WELL AS WITH THE MFR'S. THE DEVICE INVOLVED IN THE INCIDENT IS NOT AVAILABLE FOR INSPECTION, HOWEVER, SAMPLES FROM THE SAME PACKAGE WERE RETURNED TO COOPERSURGICAL ON 08/31/2009. RESULTS OF THEIR ANALYSIS ARE NOT AVAILABLE AT THIS TIME. IF ADDITIONAL INFO BECOMES AVAILABLE, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AN EXPERIENCED CLINICIAN WAS ATTEMPTING TO BREAK OFF THE SPATULA INTO THE VIAL. THE SPATULA WOULD NOT INITIALLY BREAK AT THE SCORE, EVEN WITH SOME FORCE. WHEN IT DID BREAK, THE LIQUID CONTAINING THE SPECIMEN SPLASHED INTO HER EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAP-PERFECT PLASTIC SPATULA CERVICAL CYTOLOGY COLLECTION DEVICE MKQ COOPERSURGICAL PAPPERFECT SPATULA 78027

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention