BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9.6F DIGNITY MS CT PORT

    MDR report key: 3012453 · Received March 15, 2013

    Report

    Report Number
    2518902-2013-00015
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 7, 2012
    Report Date
    March 15, 2013
    Manufacturer
    MEDCOMP
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE 9.6F PRO-FUSE PORT WITH AN 8CM PIECE OF LUMEN ATTACHED WAS RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS INDICATED ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS WERE SATISFIED. A VISUAL EXAMINATION OF THE PORT LUMEN NOTED THAT THE BROKEN EDGE OF THE LUMEN IS NARROWED OR FLATTENED, NOT ROUND. THIS TYPE OF NARROWING IS INDICATIVE OF THE CATHETER HAVING A GRADE 2 PINCH-OFF WHICH IS DESCRIBED AS "DISTORTION PRESENT WITH LUMINAL NARROWING" PRIOR TO BREAKING. CATHETERS WITH THIS DEGREE OF DISTORTION SHOULD BE CONSIDERED FOR REMOVAL. THE INFORMATION PROVIDED, ALONG WITH THE X-RAYS THAT WERE PROVIDED, NOTED THAT THE PORTS WERE IMPLANTED IN THE SUBCLAVIAN VEIN. THIS DEVICE IS CONTRAINDICATED FOR CATHETER INSERTION IN THE SUBCLAVIAN VEIN MEDIAL TO THE BORDER OF THE FIRST RIB, AN AREA WHICH IS ASSOCIATED WITH HIGHER RATES OF PINCH-OFF. IT IS LIKELY THAT THE SUBCLAVIAN PLACEMENT OF THE CATHETER LED TO PINCH-OFF. THE COMPRESSION OF THE CATHETER RESULTED IN THE FRACTURE.

    Description of Event or Problem · 1

    PORT PLACED IN THE LEFT SUBCLAVIAN VEIN. AFTER 1 YEAR THE PORT LUMEN BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110800 9.6F DIGNITY MS CT PORT INFUSION PORT LJT MEDCOMP MRCTI96001 MARM120

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention