BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET PARADIGM

    MDR report key: 451774 · Received March 26, 2003

    Report

    Report Number
    75862-2003-00045
    Event Type
    Malfunction
    Date Received
    March 26, 2003
    Date of Event
    December 23, 2002
    Report Date
    March 19, 2003
    Manufacturer
    MAERSK MEDICAL DEV. S.A. DE C.V.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2002 THE END-USER CALLED MEDTRONIC MINIMED AND STATED THAT CUSTOMER CALLED COMPLAINING ABOUT KINKED CANNULAS. IN 03/2002 MAERSK MEDICAL A/S RECEIVED THE COMPLAINT AND 4 USED SETS, 4 UNUSED SETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK SET PARADIGM SUBCUTANEOUS INFUSION SET FPA MAERSK MEDICAL DEV. S.A. DE C.V. 23" 6MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN INSULIN, INSULIN PUMP