BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYURETHANE, FLEXIBLE BRAIDED TUBING

    MDR report key: 2191036 · Received July 19, 2011

    Report

    Report Number
    1721504-2011-00226
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DTR
    PMA / PMN Number
    K883718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER, THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT DATABASE COULD NOT BE PERFORMED. THE CUSTOMER DID NOT SPECIFY IF THIS WAS THE INITIAL USE OF THE DEVICE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED. EVALUATION: METHOD: DEVICE HISTORY RECORD AND COMPLAINT DATABASE COULD NOT BE REVIEWED. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING ANGIOGRAPHIC PROCEDURES, THE HIGH PRESSURE TUBING WOULD NOT HOLD THE APPLIED PRESSURE WHILE INJECTING CONTRAST. THE CUSTOMER ALSO REPORTED THAT TUBING SETS WERE TORN DURING THE PROCEDURES. NO HARM OR INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1