BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    14 FR. DECOMPRESSION KIT

    MDR report key: 2782056 · Received September 21, 2012

    Report

    Report Number
    2782056
    Event Type
    Malfunction
    Date Received
    September 21, 2012
    Date of Event
    August 28, 2012
    Report Date
    September 21, 2012
    Manufacturer
    COOK MEDICAL INCORPORATED
    Product Code
    FEG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COLONOSCOPY AFTER RECENT BOWEL SURGERY AND HIS ABDOMEN WAS DISTENDED (ISCHEMIC BOWEL). THE DECOMPRESSION TUBE WAS FED ONTO THE GUIDE WIRE WITH NO COMPLICATIONS. WHEN ATTEMPTING TO REMOVE THE GUIDING CATHETER FROM THE DECOMPRESSION TUBE, IT BECAME DIFFICULT TO REMOVE AND THEN SNAPPED. PART OF IT REMAINED INSIDE OF THE OUTER SHEATH. THE MD NOTED NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 14 FR. DECOMPRESSION KIT TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUB FEG COOK MEDICAL INCORPORATED * C767795

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR NO OTHER THERAPIES