BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAUN

    MDR report key: 3822853 · Received May 19, 2014

    Report

    Report Number
    3822853
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    January 3, 2014
    Report Date
    February 4, 2014
    Manufacturer
    BBRAUN MEDICAL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PRIMARY TUBING WHICH WAS INFUSING CHEMOTHERAPY WAS LEAKING. THE INFUSION WAS STOPPED AND THE PATIENT DISCONNECTED. NO HARM TO THE PATIENT. THE TUBING WAS DISCARDED. REF. MFR # 9614279-2014-00005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297705 BRAUN IV TUBING FPA BBRAUN MEDICAL 363421 0061335684

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other