BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK 2 EAS ELECTROMAGNETIC TRANSMITTING STYLET AND CORFLO FEEDING TUBE

    MDR report key: 6278859 · Received January 26, 2017

    Report

    Report Number
    6278859
    Event Type
    Injury
    Date Received
    January 26, 2017
    Date of Event
    January 5, 2017
    Report Date
    January 24, 2017
    Manufacturer
    CORPAK MEDSYSTEMS, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A CORTRAK NASOGASTRIC JEJUNAL TUBE (NGJ) WAS INSERTED IN A PATIENT AND PLACEMENT WAS RADIOLOGICALLY CONFIRMED AT THE DUODENAL AREA. PEDIATRIC SURGERY WAS CONSULTED 5 DAYS LATER FOR ABDOMINAL DISTENTION AND SUSPICION FOR NECROTIZING ENTEROCOLITIS (NEC). THE PATIENT SUBSEQUENTLY UNDERWENT ABDOMINAL EXPLORATORY LAPAROTOMY THE FOLLOWING DAY WITH FINDINGS OF JEJUNAL PERFORATION LOCATED AT THE DISTAL TIP OF THE NASOGASTRIC NJ TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64710 CORTRAK 2 EAS ELECTROMAGNETIC TRANSMITTING STYLET AND CORFLO FEEDING TUBE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CORPAK MEDSYSTEMS, INC. 20-9368TRAK2

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Hospitalization| O| R