BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUMSET

    MDR report key: 3161602 · Received June 4, 2013

    Report

    Report Number
    MW5030477
    Event Type
    Malfunction
    Date Received
    June 4, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    HOSPIRA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PRIMARY PLUMSET WAS GOING TO BE USED TO DELIVER CHEMOTHERAPY DRUG, BUT TECHNICIAN NOTICED A BLACK PARTICLE IN DRIP CHAMBER PRIOR TO SPIKING IV BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247060 PRIMARY PLUMSET PRIMARY PLUMSET FPA HOSPIRA 26106 5H

    Patients

    Seq Age Sex Outcome Treatment
    1