BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTOUCH ANGIOGRAPHIC CATHETERS

    MDR report key: 2160126 · Received June 2, 2011

    Report

    Report Number
    1628221-2011-00030
    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
    DQO
    PMA / PMN Number
    K943739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. THE CUSTOMER DID NOT SPECIFY IF THIS WAS THE INITIAL USE OF THE DEVICE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED. EVAL METHOD: DEVICE HISTORY RECORD WAS REVIEWED. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON TWO SEPARATE OCCASIONS, THE HUB DETACHED FROM THE CATHETER. THE FAILURE WAS NOTICED DURING HAND INJECTION. NO FURTHER INFO WAS PROVIDED. NO HARM OR INJURY WAS REPORTED. THIS IS ONE OF TWO REPORTS FOR THIS COMPLAINT: 1628221-2011-00029.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTOUCH ANGIOGRAPHIC CATHETERS CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. E174829

    Patients

    Seq Age Sex Outcome Treatment
    1