BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREPATH PRESERVATIVE FLUID COLLECTION VIAL

    MDR report key: 2864324 · Received December 5, 2012

    Report

    Report Number
    1062336-2012-00002
    Event Type
    Injury
    Date Received
    December 5, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BD DIAGNOSTIC - TRIPATH
    Product Code
    MKQ
    PMA / PMN Number
    P970018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE VIAL WITH PRESERVATIVE FLUID (WITH SPECIMEN) SHIFTED WHILE BREAKING OFF THE COLLECTION DEVICE CAUSING THE FLUID WITH SPECIMEN SAMPLE TO SPLATTER INTO USERS FACE AND EYES CAUSING EYES TO BURN. THE USER RINSED EYES WITH EYE WASH. THE USER REPORTED THAT EYES NO LONGER BURNED AFTER WASHING AND VISION WAS NOT AFFECTED. THE USER WAS WEARING GLOVES BUT WAS NOT WEARING RECOMMENDED EYE PROTECTION. THE SUREPATH COLLECTION PRODUCT INSERT (779-07084-00) 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 ALSO INCLUDES FIRST AID INSTRUCTIONS WHICH STATE, IN CASE 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 INDICATING WARNING THAT IS REFERENCED IN THE PRODUCT INSERT. THE INCIDENT DID NOT LEAD TO DEATH OF A PATIENT OR USER. THERE WAS NO DELAY IN PATIENT SAMPLE REPORTING. NO FIELD SAFETY CORRECTIVE ACTIONS ARE PLANNED AS A RESULT OF THIS COMPLAINT AT THIS TIME.

    Description of Event or Problem · 1

    PRESERVATIVE FLUID WITH SPECIMEN SAMPLE SPLATTERED INTO USERS (CUSTOMER) FACE AND EYES CAUSING EYES TO BURN. THE CUSTOMER REPORTED: "THAT WHILE BREAKING THE COLLECTION DEVICE OFF IN THE PRESERVATIVE VIAL, THE VIAL SHIFTED CAUSING SPLATTER OF SPECIMEN AND PRESERVATIVE INTO THE USER'S FACE AND EYES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREPATH PRESERVATIVE FLUID COLLECTION VIAL SUREPATH PRESERVATIVE FLUID COLLECTION MKQ BD DIAGNOSTIC - TRIPATH 110805RJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Other