BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENTERIFLEX FEEDING TUBE

    MDR report key: 3252669 · Received July 18, 2013

    Report

    Report Number
    9612030-2013-00019
    Event Type
    Other
    Date Received
    July 18, 2013
    Date of Event
    May 24, 2013
    Report Date
    June 27, 2013
    Manufacturer
    COVIDIEN
    Product Code
    FPD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2013. AN INVESTIGATION IS CURRENTLY UNDERWAY; UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2013 THAT A CUSTOMER HAD AN ISSUE WITH AN ENTRIFLEX FEEDING TUBE. THE CUSTOMER REPORTED THAT THE DEVICE WAS PLACED ON (B)(6) 2013 AND REMOVED ON THE SAME DAY. THE CUSTOMER IS STATING THAT THE PLACEMENT OF THE DEVICE CAUSED THE PT TO HAVE A PNEUMOTHORAX. IT WAS ALSO REPORTED THAT THERE WAS NO FAILURE WITH THE PRODUCT, JUST THAT THE PLACEMENT WAS INCORRECT. DUE TO THE PT'S MEDICAL ISSUES THE LUNGS WERE NOT ABLE TO HEAL RESULTING IN MEDICAL INTERVENTION TO REDUCE THE PRESSURE IN THE CHEST. THE PT WAS ON A VENTILATOR, AND HAD AN ENDOTRACHEAL TUBE WHEN THE FEEDING TUBE WAS PLACED. THE PT WAS REPORTED TO HAVE EXPIRED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335197 ENTERIFLEX FEEDING TUBE FEEDING TUBE FPD COVIDIEN 8884720858 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention