BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7F X 60CM DUAL PRO LINE CT

    MDR report key: 3955787 · Received June 25, 2014

    Report

    Report Number
    2518902-2014-00041
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 9, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDCOMP
    Product Code
    JCY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED. WE ARE CURRENTLY WAITING TO DETERMINE IF THE SAMPLE WILL BE RETURNED FOR EVALUATION. REQUESTS FOR THE SAMPLE HAVE BEEN MADE TO THE REPORTED WITH NO RESPONSE TO DATE. WHEN THE INVESTIGATION IS COMPLETE, A FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PT IN CT WITH RIGHT INTERNAL JUGULAR VENOUS DOUBLE LUMEN POWER LINE RATED AT 5ML/SEC. LINE CLEARED FOR USE AND WAS FLUSHED AND GOOD BLOOD RETURN. UPON INJECTION OF CONTRAST A 4ML/SEC. GRAPH SHOWED RISE, PLATEAU AND THEN SUDDEN DROP IN PRESSURE LINE WAS FOUND BUSTED WITH BLOOD FLOWING OUT. LINE IMMEDIATELY CLAMPED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370306 7F X 60CM DUAL PRO LINE CT INFUSION CATHETER JCY MEDCOMP MR28037201 MFTM940

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention