BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IV FILTER SET WITH LUERLOCK

    MDR report key: 21393316 · Received February 18, 2025

    Report

    Report Number
    MW5166234
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    January 29, 2025
    Report Date
    February 10, 2025
    Manufacturer
    CODAN US CORPORATION / CODAN US CORP.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING THE PATIENT'S WEEKLY DNL-310 INVESTIGATIONAL PRODUCT INFUSION THE FACTORY SEALED CONNECTION AT THE HUB OF THE REQUIRED FILTER DISCONNECTED DURING THE 33ML FLUSH RUNNING AT 40ML/HR AND WAS FOUND TO BE LAYING ON THE FLOOR. THE PATIENT WAS SUBSEQUENTLY DISCONNECTED, HEPLOCKED, AND END OF INFUSION VITALS WERE TAKEN DUE TO THE FACT THAT ALL REMAINING DRUG IN LINE WOULD BE LOST TO REPLACEMENT OF TUBING. NP AND RC WERE NOTIFIED OF EVENT. PT. WAS OBSERVED FOR 1HR POST INFUSION WITH NOT CHANGES TO BASELINE PER PROTOCOL AND DISCHARGED HOME WITH FAMILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982985 IV FILTER SET WITH LUERLOCK SET, ADMINISTRATION, INTRAVASCULAR FPA CODAN US CORPORATION / CODAN US CORP. 73714

    Patients

    Seq Age Sex Outcome Treatment
    1 21 MO Male Required Intervention DNL-310