BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALECOT RUSSEL GASTROSTOMY CATHETER

    MDR report key: 755673 · Received November 11, 2005

    Report

    Report Number
    1820334-2005-00296
    Event Type
    Malfunction
    Date Received
    November 11, 2005
    Date of Event
    September 28, 2005
    Report Date
    October 13, 2005
    Manufacturer
    COOK, INC.
    Product Code
    EZK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE DEVICE WAS RETURNED IN A USED CONDITION. AN EXAMINATION FOUND THE INNER CATHETER SLIGHTLY ELONGATED NEAR THE BLACK INDICATOR LINE. DURING TESTING, THE INNER CATHETER SEPARATED FROM ITS BONDED POSITION AT THE DISTAL TIP EASILY WHEN PULLED. AN EXAMINATION OF THIS AREA FOUND NO EVIDENCE THAT THE TUBING WAS PROPERLY BONDED AT TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    CATHETER WAS PLACED IN AN OUTPT IN 2005. IT WAS SPONTANEOUSLY EXITED ON THE SAME DAY. THE PHYSICIAN FELT THIS SITUATION OCCURRED DUE TO THE SOFTER MATERIAL OF THE TUBING. A REPLACEMENT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALECOT RUSSEL GASTROSTOMY CATHETER CATHETER EZK COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other