BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PVC, CLEAR, CONTRAST INJECTION TUBING

    MDR report key: 2160255 · Received June 2, 2011

    Report

    Report Number
    1721504-2011-00197
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DXJ
    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: TWO USED SUSPECT DEVICE WERE RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. THE COMPLAINT DATABASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. THE CUSTOMER DID NOT SPECIFY IF THIS WAS THE INITIAL USE OF THE DEVICE. THE RETURNED DEVICES WERE FROM THE FOLLOWING LOT NUMBERS: F664336, EXPIRATION DATE: 12/31/2011, DEVICE MANUFACTURE DATE: 12/2008. F636698, EXPIRATION DATE: 08/31/2011, DEVICE MANUFACTURE DATE: 08/2008. THE COMPLAINT DATABASE WAS REVIEWED FOR THE TWO LOT NUMBERS REPORTED ABOVE. NO SIMILAR COMPLAINTS WERE FOUND. THE ROOT CAUSES OF THE FAILURE ARE ATTRIBUTED TO THE MANUFACTURING BONDING PROCESS. CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO ADDRESS THIS TYPE OF FAILURE. BOTH LOTS ABOVE WERE BUILT PRIOR TO IMPLEMENTATION OF THE NOTED CORRECTIVE ACTIONS. EVALUATION METHOD: DEVICE HISTORY RECORD WAS REVIEWED, COMPLAINT DATABASE WAS REVIEWED.

    Description of Event or Problem · 1

    THE ROTATOR BROKE DURING USE. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. NO HARM OR INJURY WAS REPORTED. THE CUSTOMER REPORTED TWO DEFECTIVE DEVICES BUT DID NOT PROVIDE ANY FURTHER INFORMATION 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 DXJ MERIT MEDICAL SYSTEMS, INC. H224504

    Patients

    Seq Age Sex Outcome Treatment
    1