BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADD-EASE BINARY CONN 20MM

    MDR report key: 2824630 · Received November 2, 2012

    Report

    Report Number
    MW5027520
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 2, 2012
    Manufacturer
    B. BRAUN
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    INFUSION INNOVATIONS RECEIVED A PHONE CALL FROM PATIENT'S HOME HEALTH NURSE. SHE STATED THAT PATIENT HAD A DOSE OF INVANZ THAT LEAKED ALL OVER. INFUSION INNOVATIONS HAD TO REPLACE THE DOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADD-EASE BINARY CONN 20MM ADD-EASE LHI B. BRAUN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR