BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET

    MDR report key: 418852 · Received September 19, 2002

    Report

    Report Number
    8021545-2002-00164
    Event Type
    Malfunction
    Date Received
    September 19, 2002
    Date of Event
    August 9, 2002
    Report Date
    September 16, 2002
    Manufacturer
    MAERSK MEDICAL DEVICES SADECV
    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 END-USER STATED THAT BGS WAS RUNNING HIGH. A LEAK WAS DETECTED WHERE TUBING CONNECTS TO RESERVOIR. ON SEPTEMBER 09, 2002 MAERSK MEDICAL A/S RECEIVED THE COMPLAINT, 2 USED AND 2 UNUSED SETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK SET SUBCUTANEOUS INFUSION SET FPA MAERSK MEDICAL DEVICES SADECV 23" - 9MM 2200197

    Patients

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