BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS 17 INCH EXT SET W/.2MF & VLV PORT

    MDR report key: 9721811 · Received February 18, 2020

    Report

    Report Number
    9616066-2020-00433
    Event Type
    Malfunction
    Date Received
    February 18, 2020
    Date of Event
    February 6, 2019
    Report Date
    April 15, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    20350E-0006/NO 510K- THIS IS AN INTERNATIONAL CODE- THE MODEL#/CATALOG# IDENTIFIED IS A CAREFUSION PRODUCT WHICH IS SAME OR SIMILAR TO A DEVICE THAT IS APPROVED FOR SALE DOMESTICALLY. THE DOMESTIC SIMILAR LIST NUMBER IS 20350E. THE 510K NUMBER PROVIDED IS FOR THE DOMESTIC SIMILAR PRODUCT.- K960280. ALTHOUGH REQUESTED, PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE PRODUCT BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE REPORTED FEEDBACK SUGGESTS THAT THERE IS BACK FLOW. DUE TO DEVICE CLOGGING, MEDICATION DELIVERY WAS AFFECTED AND DEVICE HAD TO BE CHANGED. HOWEVER, NO PATIENT OR USER HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185429 ALARIS 17 INCH EXT SET W/.2MF & VLV PORT SET, EXTENSION, INTRAVASCULAR FPA CAREFUSION 20350E-0006 17025908

    Patients

    Seq Age Sex Outcome Treatment
    1