BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B.BRAUN

    MDR report key: 6300028 · Received February 3, 2017

    Report

    Report Number
    6300028
    Event Type
    Malfunction
    Date Received
    February 3, 2017
    Date of Event
    February 18, 2016
    Report Date
    December 28, 2016
    Manufacturer
    B. BRAUN INTERVENTIONAL SYSTEMS, INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ATTACHED A CHEMO DRUG TO INFUSE AND WAS SECURE AND RUNNING. AFTER 15 MINUTES, REFLUX VALVE AND CONNECTOR HAD COME APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83315 B.BRAUN INVISION-PLUS IV CONNECTOR FPA B. BRAUN INTERVENTIONAL SYSTEMS, INC M00077

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR