BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYURETHANE CONTRAST INJECTION LINE

    MDR report key: 2012189 · Received February 1, 2011

    Report

    Report Number
    1721504-2011-00036
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    October 18, 2010
    Report Date
    January 6, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DTR
    PMA / PMN Number
    K932251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: OTHER, THE EVALUATION HAS NOT BEEN COMPLETED. A DEVICE HISTORY RECORD AND COMPLAINT DATABASE REVIEW CANNOT BE COMPLETED AS NO LOT NUMBER WAS GIVEN. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED. METHOD: DEVICE HISTORY RECORD AND COMPLAINT DATABASE CANNOT BE REVIEWED AS NO LOT NUMBER WAS GIVEN. CONCLUSION: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE LEAKED. NO HARM OR INJURY WAS REPORTED. THE CUSTOMER REPORTED TWO DEFECTIVE DEVICES. THE CUSTOMER WAS UNABLE TO PROVIDE SPECIFIC INFORMATION OR CLINICAL DETAILS FOR THE ADDITIONAL EVENT. THE CUSTOMER RETURNED ONLY ONE USED DEVICE FOR EVALUATION. THEREFORE, THIS SINGLE FORM 3500A REPORT WILL BE SUBMITTED FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYURETHANE CONTRAST INJECTION LINE DISPLAY, CATHODE RAY-TUBE, MEDICAL DTR MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1