BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTRAK 2 EAS ELECTROMAGNETIC TRANSMITTING STYLET AND CORFLO FEEDING TUBE

    MDR report key: 7326666 · Received March 9, 2018

    Report

    Report Number
    7326666
    Event Type
    Malfunction
    Date Received
    March 9, 2018
    Date of Event
    March 4, 2018
    Report Date
    March 7, 2018
    Manufacturer
    CORPAK MEDSYSTEMS, INC.
    Product Code
    FPD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE STYLET FOR THE CORTRACK 2 PROVIDED AN INITIAL READING ON THE MONITOR WHEN INSERTED, THE STYLET WAS REMOVED INDEPENDENTLY OF THE FEEDING TUBE, THEN REINSERTED TO CAPTURE THE READING ON THE CORTRACK MONITOR, BUT IT DID NOT PRODUCE A READING/PICTURE ON THE MONITOR, THERE WAS AN ERROR READING ON THE SCREEN IDENTIFYING A PROBLEM. UPON REMOVAL OF THE STYLET IT WAS OBSERVED TO SHREDDED/UNRAVLED, WHICH WAS THE RED/ORANGE WIRE ON THE STYLET. A NEW STYLET WAS REPLACED, WHICH OPERATED WITHOUT DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171223 CORTRAK 2 EAS ELECTROMAGNETIC TRANSMITTING STYLET AND CORFLO FEEDING TUBE TUBE, FEEDING FPD CORPAK MEDSYSTEMS, INC. 20-9432TRAK2A 79661

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR