BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1067634 · Received June 23, 2008

    Report

    Report Number
    1067634
    Event Type
    Malfunction
    Date Received
    June 23, 2008
    Date of Event
    June 15, 2008
    Report Date
    June 23, 2008
    Manufacturer
    VIASYS HEALTHCARE MEDSYSTEMS
    Product Code
    FPD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAFF REPORT THAT THE PATIENT'S DOBHOFF FEEDING TUBE WAS INSERTED WITHOUT DIFFICULTY AND THAT PLACEMENT WAS CONFIRMED BY X-RAY. HOWEVER, WHEN THE RN TRIED TO REMOVE THE STYLET, SHE WAS UNABLE TO DO SO. ANOTHER RN ON THE FLOOR TRIED TO REMOVE THE STYLET, AND ALSO WAS UNSUCCESSFUL. A NEW DOBBHOFF FEEDING TUBE FROM THE SAME LOT NUMBER WAS EASILY INSERTED. PLACEMENT WAS CONFIRMED BY X-RAY AND STAFF TRIED TO REMOVE ITS STYLET. AGAIN, THE STYLET WAS STUCK AND WOULD NOT COME OUT. STAFF REMOVED THE SECOND FEEDING TUBE, AND INSERTED A THIRD ONE - THIS ONE FROM A DIFFERENT LOT NUMBER. IT ALSO WAS EASILY INSERTED AND PLACEMENT WAS CONFIRMED BY X-RAY. THE STYLET ON THIS LAST FEEDING TUBE WAS EASILY REMOVED. STAFF SUSPECTED THAT SOMETHING WAS WRONG WITH THE FEEDING TUBES FROM THIS LOT NUMBER AND PULLED ALL PRODUCT FROM THIS LOT. HOWEVER, WHEN TESTING A NEWLY OPENED PRODUCT FROM THIS LOT NUMBER THAT HAD NOT BEEN USED ON A PATIENT, WE WERE UNABLE TO REPRODUCE THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * FEEDING TUBE, ENTERAL FPD VIASYS HEALTHCARE MEDSYSTEMS * 30207

    Patients

    Seq Age Sex Outcome Treatment
    1 *