BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUREPATH PRESERVATIVE FLUID COLLECTION DEVICE

    MDR report key: 2963925 · Received February 13, 2013

    Report

    Report Number
    1062336-2013-00001
    Event Type
    Other
    Date Received
    February 13, 2013
    Report Date
    May 2, 2007
    Manufacturer
    BD DIAGNOSTICS-TRIPATH
    Product Code
    MKQ
    PMA / PMN Number
    P970018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS DOCUMENTED VIA CALL ID (B)(6). THE EXTENT OF THE EVENT AND THE PRECAUTIONS TAKEN BY THE USERS ARE UNK. ACTIONS TAKEN BY THE USERS THAT WERE SPLASHED ARE ALSO UNK. THE SUREPATH COLLECTION PRODUCT INSERT (779-0704-00) INDICATES PRECAUTIONS THAT STATE GOOD LABORATORY PRACTICES SHOULD BE FOLLOWED AND ALL PROCEDURES FOR USE OF THE PREPSTAIN SYSTEM SHOULD BE STRICTLY OBSERVED. THE PRECAUTIONS ALSO STATE TO AVOID SPLASHING AND GENERATING AEROSOLS AND THAT OPERATORS SHOULD USE APPROPRIATE HAND, EYE, AND CLOTHING PROTECTION. THE INSERT INCLUDES FIRST AID INSTRUCTIONS WHICH STATE, IN CAUSE OF CONTACT, IMMEDIATELY FLUSH SKIN WITH WATER; IMMEDIATELY FLUSH EYES WITH PLENTY OF WATER FOR AT LEAST 15 MINUTES. THE VIAL IS LABELED WITH A SYMBOL (CHANGE !) INDICATING WARNING THAT IS REFERENCED IN THE PRODUCT INSERT. DELAY IN PT SAMPLE REPORTING WAS NOT INDICATED. NO SAFETY CORRECTIVE ACTIONS ARE PLANNED AS A RESULT OF THIS COMPLAINT AT THIS TIME.

    Description of Event or Problem · 1

    SOME CLINICIANS WERE GETTING SPLASHED USING THE SNAP METHODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63834 SUREPATH PRESERVATIVE FLUID COLLECTION DEVICE SPATULA/COLLECTION DEVICE MKQ BD DIAGNOSTICS-TRIPATH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other