BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV ADMIN SET, 15DRP, 3 NF PORTS, 109"

    MDR report key: 19650693 · Received July 1, 2024

    Report

    Report Number
    1417592-2024-00701
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    May 28, 2024
    Report Date
    July 1, 2024
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    FPA
    UDI-DI
    20080196760029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT "WHILE INFUSING FLUID, THE PATIENT MOVED ARM AND THE TUBING CAME COMPLETELY APART INTO TWO PIECES AT THE CLOSEST Y PORT TO THE IV". NO INJURY WAS REPORTED. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    TUBING CAME APART AT THE Y PORT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1348910 IV ADMIN SET, 15DRP, 3 NF PORTS, 109" FPA MEDLINE INDUSTRIES LP 20080196760029

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention| O