BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F PRO-FUSE CT PLAST PORT

    MDR report key: 1950238 · Received December 10, 2010

    Report

    Report Number
    2518902-2010-00079
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    October 18, 2010
    Report Date
    December 8, 2010
    Manufacturer
    MEDCOMP
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    ONE PRO-FUSE PORT WITH LUMEN WAS RETURNED FOR EVAL. A VISUAL EXAMINATION OF THE LUMEN REVEALED A NARROWING OF THE LUMEN 7CM FROM THE PORT BODY. A LONGITUDINAL SLIT IS PRESENT ON THE LUMEN ON THE UNDERSIDE OF THE COMPRESSION SECTION. THE LUMEN WAS MEASURED AND FOUND TO CONFORM TO THE DIMENSIONAL SPECIFICATIONS. COPIES OF PATIENT X-RAYS WERE RECEIVED AND REVIEWED. THE LUMEN WAS NOTED TO BE VISIBLY COMPRESSED OVER THE CLAVICLE. THIS IS CONSIDERED A GRADE 2 DISTORTION/PINCH OFF. ACCORDING TO THE INSTRUCTIONS FOR USE, THIS PORT SHOULD NOT HAVE BEEN USED FOR AN INJECTION STUDY. REMOVAL OF A PORT WITH GRADE 2 DISTORTION SHOULD BE CONSIDERED. IT APPEARS THAT THE CATHETER BECAME COMPRESSED OVER THE CLAVICLE CAUSING IT TO FAIL DURING THE INJECTION STUDY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LUMEN LEAKED DURING INJECTION STUDY, OVER CLAVICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F PRO-FUSE CT PLAST PORT CT INJECTABLE PORT LJT MEDCOMP MRCTT80001 MAVC150

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention