BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    500 ML TPN BAG

    MDR report key: 8014522 · Received October 29, 2018

    Report

    Report Number
    1416980-2018-06866
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Date of Event
    October 4, 2018
    Report Date
    November 20, 2018
    Manufacturer
    SET, I.V. FLUID TRANSFER
    Product Code
    LHI
    UDI-DI
    00085412477220
    PMA / PMN Number
    K900585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 500ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG WAS LEAKING FROM THE MEMBRANE (MIDDLE) PORT. THE DEVICE WAS FILLED WITH TRYPTIC SOY BROTH (TSB). THE LEAK WAS DISCOVERED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855440 500 ML TPN BAG SET, I.V. FLUID TRANSFER LHI SET, I.V. FLUID TRANSFER NA 60119800 00085412477220

    Patients

    Seq Age Sex Outcome Treatment
    1