BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3CC BARREL REG WOS CLR

    MDR report key: 8483316 · Received April 4, 2019

    Report

    Report Number
    1017768-2019-00614
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Date of Event
    April 1, 2019
    Report Date
    April 4, 2019
    Manufacturer
    COVIDIEN
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES: THE 3CC TUBES ARE NOT CLEAR AT THE BOTTOM AND SEEM THAT THERE WAS A PROBLEM WITH THIS BATCH OF TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278617 3CC BARREL REG WOS CLR SYRINGE, PISTON FMF COVIDIEN 5551781305 830581

    Patients

    Seq Age Sex Outcome Treatment
    1