BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET PARADIGM

    MDR report key: 428121 · Received November 8, 2002

    Report

    Report Number
    8021545-2002-00226
    Event Type
    Malfunction
    Date Received
    November 8, 2002
    Date of Event
    August 5, 2002
    Report Date
    November 7, 2002
    Manufacturer
    MAERSK MEDICAL A/S
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE END-USER STATED THAT THE SOFT CANNULAS WERE BENDING. ON OCTOBER 24, 2002 MAERSK MEDICAL A/S RECEIVED THE COMPLAINT AND 1 USED BASE PIECE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other 1) INSULIN, 2) INSULIN INFUSION PUMP.