BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5F DIGNITY CT PORT

    MDR report key: 4683788 · Received April 7, 2015

    Report

    Report Number
    2518902-2015-00040
    Event Type
    Injury
    Date Received
    April 7, 2015
    Date of Event
    February 18, 2015
    Report Date
    April 7, 2015
    Manufacturer
    MEDCOMP
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE PROT REVEALED THE PORT HAS A RAISED PROTRUSION ON THE BOTTOM OF THE PORT BASE. A FUNCTIONAL EVALUATION DETERMINED THE MARK TO BE A PIN HOLD THAT LEKS WHEN THE PORT IS FLUSHED. THE HOLE APPEARS TO BE THE RESULT OF S NEEDLE EXITING THE FLOOR OF THE PORT. A REVIEW OF THE ENGINEERING FILES NOTED THAT IT REQUIRED 14.17 LBS OF FORCE TO PUNCTURE THE PORT BASE WITH 19GA NEEDLE. THE 22GA NEEDLES BENT PRIOR TO PUNCTURING THE BASES. WE ARE UNABLE TO DETERMINE THE CAUSE OF THIS EVENT. EXCESSIVE FORCE MAY HAVE BEEN USED WHEN ACCESSING THE PORT.

    Description of Event or Problem · 1

    THE IMPLANTED DEVICE WAS REMOVED FROM THE PATIENT (A CHILD;) BECAUSE HE FEELS DISCOMFORT FROM THE FIRST MONTH AFTER THE IMPLANTATION PROCEDURE. WHEN INTRODUCING PRESSURE TO THE RESERVOIR; THE PHYSICIAN OBSERVED A HOLE AT THE BOTTOM OF THE LETTER T.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227486 5F DIGNITY CT PORT INFUSION PORT LJT MEDCOMP MCT150041M UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention 22G, 19MM PORT ACCESS NEEDLE