BEUDAMED
    FDA Adverse Event Other Summary report: N

    FEEDING TUBE

    MDR report key: 169742 · Received May 28, 1998

    Report

    Report Number
    1314412-1998-00010
    Event Type
    Other
    Date Received
    May 28, 1998
    Date of Event
    March 27, 1998
    Report Date
    April 30, 1998
    Manufacturer
    SHERWOOD DAVIS AND GECK
    Product Code
    FPD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROGRESS. CUSTOMER REPORTS THEY DO NOT FLUSH THE TUBE PRIOR TO INSERTION OR REMOVAL OF THE SYTLET. THIS CONSTITUTES A MISUSE OF THE PRODUCT BY FAILURE TO FOLLOW MFR'S INSTRUCTIONS FOR USE. ONE SAMPLE WAS RETURNED FOR EVALUATION. FUNCTIONAL TESTING OF THE PRODUCT FOUND THAT THE SYLET WAS EASILY REMOVED AFTER THE PROPER AMOUNT OF WATER WAS ADDED TO THE TUBE. STYLET WAS USED WITH FEEDING TUBE 8884-720841 (LOT #981046). NO PROBLEMS WERE FOUND WITH EITHER PRODUCT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS, THEY WERE UNABLE TO REMOVE THE GUIDEWIRE FROM A FEEDING TUBE ONCE THE TUBE HAD BEEN PLACED IN THE PT. THE TUBE HAD TO BE REMOVED AND ANOTHER TUBE PLACED. NO PT INJURY IS REPORTED, BUT A SECOND INTUBATION WAS NECESSARY.

    Description of Event or Problem · 2

    CUSTOMER REPORTS, THEY WERE UNABLE TO REMOVE THE GUIDEWIRE FROM A FEEDING TUBE ONCE THE TUBE HAD BEEN PLACED IN THE PT. THE TUBE HAD TO BE REMOVED AND ANOTHER TUBE PLACED. NO PT INJURY IS REPORTED, BUT A SECOND INTUBATION WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEEDING TUBE FEEDING TUBE FPD SHERWOOD DAVIS AND GECK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN
    2 *