BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFEGUIDE

    MDR report key: 5688195 · Received May 31, 2016

    Report

    Report Number
    5688195
    Event Type
    Malfunction
    Date Received
    May 31, 2016
    Date of Event
    May 13, 2016
    Report Date
    May 23, 2016
    Manufacturer
    MEDOVATIONS, INC.
    Product Code
    KNQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COVERING ON THE END OF THE GUIDEWIRE WAS REMOVED. THE SCRUB TECH THOUGHT HE PUT IT ON THE BACK TABLE. IT APPARENTLY FELL INTO A CONTAINER THAT HAD LUBRICANT IN IT AND WAS USED TO LUBRICATE THEN ENDOSCOPE. THE CAP, WHICH IS CLEAR IN COLOR AS IS THE LUBRICANT, WAS RUBBED ONTO THE ENDOSCOPE AND PLACED IN THE PATIENT. IT WOULD BE SAFER IF THE CAP WAS A BRIGHT COLOR SO THE TEAM CAN SEE IT MORE EASILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344063 SAFEGUIDE DILATOR, ESOPHAGEAL, GUIDEWIRE KNQ MEDOVATIONS, INC. 1214-02 217116

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR NO