BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREFPLUS 1CC X 31G INS SYR

    MDR report key: 1250848 · Received November 25, 2008

    Report

    Report Number
    1915484-2008-00065
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Report Date
    November 12, 2008
    Manufacturer
    COVIDIEN
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 11/21/2008. AN INVESTIGATION IS CURRENTLY UNDERWAY; UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN IN 2008 THAT A CUSTOMER HAD AN ISSUE WITH AN INSULIN NEEDLE/SYRINGE. THE CUSTOMER REPORTS THAT CANNULA IS BREAKING WHEN INJECTING INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREFPLUS 1CC X 31G INS SYR INSULIN NEEDLE/SYRINGE FMF COVIDIEN 8881608131 823106

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK