BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPTY CONTAINER

    MDR report key: 6321714 · Received February 8, 2017

    Report

    Report Number
    MW5067802
    Event Type
    Malfunction
    Date Received
    February 8, 2017
    Date of Event
    February 8, 2017
    Report Date
    February 8, 2017
    Manufacturer
    HOSPIRA
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    HOSPIRA EMPTY CONTAINER, 100-ML CAPACITY FLEXIBLE IV BAG, LIST NO. 7951-23. WHEN ENTERING THE ADMIXTURE PORT WITH SYRINGE NEEDLE, THE DIAPHRAGM SEPARATES PARTIALLY OR COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94277 EMPTY CONTAINER EMPTY CONTAINER KPE HOSPIRA

    Patients

    Seq Age Sex Outcome Treatment
    1