BEUDAMED
    FDA Adverse Event Death Summary report: N

    DOVER

    MDR report key: 6538679 · Received May 2, 2017

    Report

    Report Number
    1282497-2017-05119
    Event Type
    Death
    Date Received
    May 2, 2017
    Date of Event
    December 28, 2015
    Report Date
    December 27, 2017
    Manufacturer
    COVIDIEN
    Product Code
    KOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 05/02/2017. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS BEING USED AS A FEEDING TUBE. A FOLEY CATHETER WAS USED DUE TO THE LACK OF AVAILABILITY OF GASTRONOMY TUBES FOR VERY SMALL INFANTS. THE REPORT REFERS TO PRODUCT CODE 8887603085, FOLEY SIL CATH 3ML 8CH X10 WITH AN UNKNOWN LOT NUMBER. A DEVICE HISTORY RECORD WAS NOT PERFORMED BECAUSE THERE WAS NO LOT NUMBER PROVIDED IN THE COMPLAINT FILE. NO PICTURE OR SAMPLE WAS PROVIDED FOR EVALUATION THEREFORE THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. A POSSIBLE ROOT CAUSE CANNOT BE PROVIDED AS THE DAMAGE REPORTED NEEDS TO BE EVALUATED AND IN WHICH PART OF THE CATHETER TO PROVIDE AN ACCURATE STATEMENT. NO CORRECTIVE ACTIONS WILL APPLY SINCE THE CONDITION WAS NOT CONFIRMED AND A SAMPLE IS REQUIRED TO PROVIDE A MORE ACCURATE ROOT CAUSE. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE CUSTOMER REPORTS THAT THE SURGEON INSERTED THE DEVICE ON A NEONATE. THE CATHETER DEVELOPED A CRACK/RUPTURE TWO DAYS LATER AND IT WAS NOTED THAT THE DEVICE WAS ACTIVELY LEAKING. THE CATHETER HAD TO BE REPLACED WITH A NEW CATHETER. THIS IS A UROLOGY CATHETER THAT WAS BEING USED AS A FEEDING TUBE ON A PREMATURE INFANT. THE FOLEY CATHETER WAS USED DUE TO THE LACK OF AVAILABILITY OF GASTRONOMY TUBES FOR VERY SMALL INFANTS. ON (B)(6) 2017, COVIDIEN WAS NOTIFIED THAT THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318898 DOVER KOD COVIDIEN 8887603085

    Patients

    Seq Age Sex Outcome Treatment
    1 Death