BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLOW MAX SAFETY

    MDR report key: 2839279 · Received November 14, 2012

    Report

    Report Number
    2839279
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 14, 2012
    Manufacturer
    CORPAK MEDSYSTEMS, INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CORFLO-MAX SAFETY PEG TUBE BEING INSERTED. AT END OF PROCEDURE THE MD WAS UNABLE TO SEPARATE THE LOOPED PLACEMENT WIRE FROM THE SELDINGER NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORFLOW MAX SAFETY TUBE, PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KNT CORPAK MEDSYSTEMS, INC. * 60190

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR