BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET PARADIGM

    MDR report key: 437320 · Received December 11, 2002

    Report

    Report Number
    75862-2002-00004
    Event Type
    Malfunction
    Date Received
    December 11, 2002
    Date of Event
    October 28, 2002
    Report Date
    December 6, 2002
    Manufacturer
    MAERSK MEDICAL DEVICE S.A. DE C.V.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SOFT CANNULA WAS BENT WHEN IT WAS REMOVED. ON NOVEMBER 22, 2002 MAERSK MEDICAL A/S RECEIVED THE COMPLAINT AND 1 USED INFUSION SET 2 USED CANNULA PARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK SET PARADIGM SUBCUTANEOUS INFUSION SET FPA MAERSK MEDICAL DEVICE S.A. DE C.V. 43" - 9MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other INSULIN, INFUSION PUMP, SYRINGE/RESERVOIR.