BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PVC, CLEAR, CONTRAST INJECTION TUBING

    MDR report key: 2193001 · Received July 21, 2011

    Report

    Report Number
    1721504-2011-00229
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 28, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    FPK
    PMA / PMN Number
    K883718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SUSPECT DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. THE CUSTOMER DID NOT SPECIFY IF THIS WAS THE INITIAL USE OF THE DEVICE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. EVALUATION: CONCLUSIONS: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN AORTIC ANGIOGRAPHY PROCEDURE THE ROTATOR BROKE. NO HARM OR INJURY WAS REPORTED. THE CUSTOMER REPORTED TWO DEFECTIVE DEVICES BUT DID NOT PROVIDE ANY FURTHER INFO OR CLINICAL DETAILS FOR THE ADDITIONAL EVENT. THEREFORE, THIS SINGLE FORM FDA 3500A WILL BE SUBMITTED FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PVC, CLEAR, CONTRAST INJECTION TUBING DISPLAY, CATHODE RAY-TUBE, MEDICAL FPK MERIT MEDICAL SYSTEMS, INC. F671123

    Patients

    Seq Age Sex Outcome Treatment
    1