BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL

    MDR report key: 3899033 · Received May 20, 2014

    Report

    Report Number
    1060680-2014-00011
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    BENLAN, INC.
    Product Code
    FPD
    PMA / PMN Number
    K100700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM: THE MEDICAL CENTER REPORTED THAT ALL SIZES OF THE DEROYAL NEONATAL FEEDING TUBES (ADAPTOR END) ARE STRETCHING OUT ONCE THE EXTENSION SET WITH CLAMP STYAS CONNECTED FOR A SPAN OF TIME. DUE TO THE ISSUE, THE CLINICIANS ARE HAVING TO USE BOTH HANDS TO DRAW THE RESIDUAL BACK. DEROYAL: THE REPORTED DEVICE HAS NOT BEEN RETURNED TO DEROYAL AT THIS TIME FOR EVALUATION. THE INVESTIGATION INTO THE ROOT CAUSE IS IN PROCESS. IT HAS BEEN IDENTIFIED THAT AFTER REMOVING THE EXTENSION SET, IF THE CONNECTOR IS NOT GIVEN TIME TO SHRINK BACK TO ITS ORIGINAL SIZE AND THE CLINICIAN USES A SMALL SYRINGE (1-10CC) THEN THE CONNECTOR MAY BE LOOSE AND THEY WILL NOT BE ABLE TO GET A GOOD DRAW. TESTING IS BEING PERFORMED TO COMPARE THE USE OF 1-10CC SYRINGES TO THE 20-60CC ENTERAL SYRINGES AND EXTENSION SETS.

    Description of Event or Problem · 1

    THE MEDICAL CENTER REPORTED THAT ALL SIZES OF THE DEROYAL NEONATAL FEEDING TUBES (ADAPTOR END) ARE STRETCHING OUT ONCE THE EXTENSION SET WITH CLAMP STYAS CONNECTED FOR A SPAN OF TIME. DUE TO THE ISSUE, THE CLINICIANS ARE HAVING TO USE BOTH HANDS TO DRAW THE RESIDUAL BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299237 DEROYAL GASTROINTESTINAL TUBE AND ACCESSORIE FPD BENLAN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other