BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IV ADMIN SET, 15DRP, 2 NF PORTS, 108"

    MDR report key: 18377826 · Received December 21, 2023

    Report

    Report Number
    1417592-2023-00516
    Event Type
    Injury
    Date Received
    December 21, 2023
    Date of Event
    November 28, 2023
    Report Date
    December 21, 2023
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    FPA
    UDI-DI
    10884389975954
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, THERE HAVE "MULTIPLE" OCCURRENCES WHERE THE "DISTAL PORT BEGINS LEAKING" WITHIN AN "HOUR TO A COUPLE HOURS" OF USE. THE CUSTOMER REPORTED THE TUBING IS LEAKING "LACTATED RINGERS AND PROPOFOL". THE CUSTOMER REPORTED THEY REPLACED THE IV TUBING AFTER THE REPORTED INCIDENT OCCURRED. THE CUSTOMER REPORTED THE "PATIENTS ARE FINE". THE CUSTOMER REPORTED NO SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW-UP CARE RELATED TO THE REPORTED INCIDENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. SAMPLE REQUESTED FOR RETURN EVALUATION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. 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, THERE HAVE "MULTIPLE" OCCURRENCES WHERE THE "DISTAL PORT BEGINS LEAKING" WITHIN AN "HOUR TO A COUPLE HOURS" OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297470 IV ADMIN SET, 15DRP, 2 NF PORTS, 108" FPA MEDLINE INDUSTRIES, LP 0332303A065 10884389975954

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other