BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3000 ML TPN BAG

    MDR report key: 8221985 · Received January 7, 2019

    Report

    Report Number
    1416980-2018-08212
    Event Type
    Malfunction
    Date Received
    January 7, 2019
    Date of Event
    December 11, 2018
    Report Date
    February 7, 2019
    Manufacturer
    SET, I.V. FLUID TRANSFER
    Product Code
    LHI
    PMA / PMN Number
    K900585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION : THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND DEFECTS WERE OBSERVED ON THE BOTTOMED RIGHT WELD OF THE BAG. FUNCTIONAL TESTING WAS ALSO PERFORMED AND LEAKING WAS OBSERVED FROM THE UNSEALED BOTTOM RIGHT WELDS OF THE BAG. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THIS ISSUE IS BEING FURTHER INVESTIGATED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED ON EXACTAMIX 3000 ML EVA TPN BAG WAS OBSERVED LEAKING FROM "FROM THE PRINT ON THE BAG". THE LEAK WAS DISCOVERED DURING MIXING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13891 3000 ML TPN BAG SET, I.V. FLUID TRANSFER LHI SET, I.V. FLUID TRANSFER NA 60137157

    Patients

    Seq Age Sex Outcome Treatment
    1