BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PVC, CLEAR, CONTRAST INJECTION TUBING

    MDR report key: 2102234 · Received May 17, 2011

    Report

    Report Number
    1721504-2011-00165
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DTR
    PMA / PMN Number
    K883718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: OTHER, THE SUSPECT DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD DID REVEAL EXCEPTION DOCUMENTS. THE COMPLAINT DATABASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. THE CUSTOMER REPORTED THAT THEY WERE UNSURE IF THE LOT NUMBER REPORTED WAS CORRECT. UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED FAILURE WITHOUT THE SUSPECT DEVICE. NO CONCLUSION CAN BE DRAWN. EVALUATION METHOD: DEVICE HISTORY RECORD WAS REVIEWED, COMPLAINT DATABASE WAS REVIEWED. RESULTS: OTHER, UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED FAILURE WITHOUT THE SUSPECT DEVICE. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INJECTOR TUBING CAME APART ON INJECTION. THE DEVICE WAS DISCARDED AT THE HOSPITAL. 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 DTR MERIT MEDICAL SYSTEMS, INC. H201908

    Patients

    Seq Age Sex Outcome Treatment
    1