BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC QUICK SET

    MDR report key: 3242974 · Received July 22, 2013

    Report

    Report Number
    MW5030978
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    January 1, 2012
    Report Date
    July 22, 2013
    Manufacturer
    MEDTRONIC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    INFUSION SET IS NOT FITTING TOGETHER PROPERLY WITH THE RESERVOIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340363 MEDTRONIC QUICK SET QUICK INFUSION SET FPA MEDTRONIC MMT396
    340364 RESERVOIR RESERVOIR FMF MEDTRONIC MMT326A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other