BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTRAK 2 EAS ELECTROMAGNETIC TRANSMITTING STYLET AND CORFLO FEEDING TUBE

    MDR report key: 6960968 · Received October 19, 2017

    Report

    Report Number
    6960968
    Event Type
    Malfunction
    Date Received
    October 19, 2017
    Date of Event
    October 4, 2017
    Report Date
    October 12, 2017
    Manufacturer
    CORPAK MEDSYSTEMS, INC.
    Product Code
    KNT
    UDI-DI
    10815149023608
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON PREPARING A CORTRAK 2 FEEDING TUBE FOR INSERTION, THE RN NOTICED THE GUIDE-WIRE PROTRUDING INTO THE EXIT OPENING OF THE TUBE. THE TUBE WAS REMOVED FROM SERVICE. HIS SAFETY CONCERN IS THAT THE GUIDE-WIRE COULD POTENTIALLY HARM A PATIENT IF INSERTED. THE GUIDE-WIRE TIPS ARE TYPICALLY A COUPLE OF CENTIMETERS PROXIMAL TO THE TIP OF THE TUBE. THE RN DIRECTLY INVOLVED IN THIS EVENT CONTACTED THE CORPAK MEDSYSTEMS/HALYARD SALES REP IMMEDIATELY, AND SHE STATED SHE WOULD CONTACT HER QUALITY SERVICE DEPARTMENT AND WILL MAKE ARRANGEMENTS TO REPLACE OUR STOCK OF TUBES. UPON INSPECTION OF THE REMAINING UNOPENED TUBES IT APPEARS THERE ARE OTHER TUBES WITH SIMILAR ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741760 CORTRAK 2 EAS ELECTROMAGNETIC TRANSMITTING STYLET AND CORFLO FEEDING TUBE TUBE, FEEDING KNT CORPAK MEDSYSTEMS, INC. 20-9551TRAK2A 79092 10815149023608

    Patients

    Seq Age Sex Outcome Treatment
    1