BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV ADMIN SET, 15DRP, 3 NF PORTS, 112"

    MDR report key: 19181674 · Received April 25, 2024

    Report

    Report Number
    1417592-2024-00547
    Event Type
    Malfunction
    Date Received
    April 25, 2024
    Date of Event
    March 28, 2024
    Report Date
    April 25, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    FPA
    UDI-DI
    20884389975968
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, "THE DISTAL PORT ON THE THE IV TUBING LEAKS AT TIMES. I'M NOT SURE IF THE VALVE GETS STUCK OR WHAT. I ALWAYS USE THE 60 IN EXTENSION TUBING AND PLACE ON DISTAL PORT WITH PROPOFOL RUNNING. SOME TIMES IT LEAKS, SOMETIMES IT DOESN'T. ONCE THE LEAK IS NOTICED THE EXTENSION TUBING IS PLACED ON A DIFFERENT PORT UNTIL THE CASE IS OVER". 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

    ACCORDING TO THE CUSTOMER, "THE DISTAL PORT ON THE THE IV TUBING LEAKS AT TIMES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1659437 IV ADMIN SET, 15DRP, 3 NF PORTS, 112" FPA MEDLINE INDUSTRIES, LP 760853441 20884389975968

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown