BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRELLIS 8 120X30

    MDR report key: 2990203 · Received March 5, 2013

    Report

    Report Number
    2953189-2013-00027
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 16, 2013
    Report Date
    February 16, 2013
    Manufacturer
    COVIDIEN SAN JOSE
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOUND NO DEFECTS FOUND RELATED TO THE REPORTED INCIDENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT YET RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE PHYSICIAN USED TRELLIS IN A STRAIGHT LINE THROUGH THE JUGULAR VEIN. THE TRELLIS CATHETER APPEARED TO NOT BE OSCILLIATING DURING TREATMENT. THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT AND FOUND THE CATHETER KINKED AND PARTIALLY BROKEN. THE CATHETER DID NOT DETACH IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92734 TRELLIS 8 120X30 CATHETER, CONTINUOUS FLUSH KRA COVIDIEN SAN JOSE BVT812030 551595

    Patients

    Seq Age Sex Outcome Treatment
    1 Other