BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCLEAN-RING ENTERAL FEEDING TUBE SET

    MDR report key: 2181937 · Received November 30, 2007

    Report

    Report Number
    1820334-2007-00455
    Event Type
    Injury
    Date Received
    November 30, 2007
    Date of Event
    September 25, 2007
    Report Date
    November 2, 2007
    Manufacturer
    COOK INCORPORATED
    Product Code
    DQY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: THE DISTAL END OF THE CATHETER, MEASURING APPROX 14CM, WAS RETURNED IN A USED CONDITION WITH A KNOT LOOPED IN THE CENTER OF THE TUBING. BASED UPON THE INFO PROVIDED AND THE CONDITION OF THE DEVICE, IT IS FEASIBLE TO SAY THE KNOT FORMED DURING PLACEMENT, AS A RESULT OF PT ANATOMY OR FROM POSSIBLE PT INTERVENTION. THIS IS A SOFT, PLIABLE TUBING DESIGNED FOR PT COMFORT THAT CAN BE MANIPULATED. ADDITIONAL INFO FROM THE USER FACILITY REPORT: (B)(6).

    Description of Event or Problem · 1

    FEEDING TUBE WAS PLACED (B)(6) 2007 WITHOUT COMPLICATIONS. THEN ON (B)(6) 2007, AN ATTEMPT WAS MADE TO IRRIGATE THE TUBE WHEN THE LINE COULD NOT BE FLUSHED. UPON REMOVAL OF THE FEEDING TUBE, IT WAS NOTED THE DISTAL END HAD BECOME TIED IN A KNOT. ADD'L INFO FROM THE USER FACILITY REPORT: ATTEMPTED TO IRRIGATE PT'S FEEDING TUBE, UNABLE TO FLUSH LINE, UPON REMOVAL DISTAL END OF FEEDING TUBE WAS NOTED TIED IN A KNOT. NO INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCLEAN-RING ENTERAL FEEDING TUBE SET DQY ENTERAL FEEDING TUBE DQY COOK INCORPORATED NA 1905390

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention