BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1ML SAF. SYR ETB 28X1/2

    MDR report key: 8628447 · Received May 21, 2019

    Report

    Report Number
    1915484-2019-01053
    Event Type
    Malfunction
    Date Received
    May 21, 2019
    Date of Event
    May 13, 2019
    Report Date
    May 21, 2019
    Manufacturer
    COVIDIEN
    Product Code
    FMF
    UDI-DI
    20884521014968
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. IF ADDITIONAL INFORMATION OR THE SAMPLE IS RECEIVED, THE INVESTIGATION WILL BE REOPENED AND RESPONDED TO ACCORDINGLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PLUNGER WAS STICKING AND HARD TO MANEUVER AND THE CAPS WERE COMING APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420144 1ML SAF. SYR ETB 28X1/2 SYRINGE, PISTON FMF COVIDIEN 8881511201 729820X 20884521014968

    Patients

    Seq Age Sex Outcome Treatment
    1