BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSAFE IV FILTER SET WITH LUERLOCK

    MDR report key: 6935725 · Received October 10, 2017

    Report

    Report Number
    MW5072663
    Event Type
    Injury
    Date Received
    October 10, 2017
    Date of Event
    October 5, 2017
    Report Date
    October 5, 2017
    Manufacturer
    CODAN US CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NURSING NOTED THAT TUBING WAS LEAKING AT THE SITE OF THE MICROFILTER. TUBING CHANGED OUT AND RESERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718892 LIGHTSAFE IV FILTER SET WITH LUERLOCK SET, ADMINISTRATION, INTRAVASCULAR FPA CODAN US CORPORATION 72269

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Required Intervention