BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFLEX TESIO CATHETER

    MDR report key: 2212695 · Received August 11, 2011

    Report

    Report Number
    2518902-2011-00081
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    June 18, 2011
    Report Date
    August 11, 2011
    Manufacturer
    MEDCOMP
    Product Code
    MSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE VENOUS TESIO EXTENSION ASSEMBLY WAS RETURNED FOR EVALUATION. A VISUAL EXAMINATION OF THE DEVICE REVEALED THAT THE LUER PULLED OUT OF THE EXTENSION TUBING. THE LUER AND THE EXTENSION TUBING ARE DISCOLORED AND SHOW SIGNS OF WEAR. A REVIEW OF THE MANUFACTURING RECORDS INDICATED ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS WERE SATISFIED. A REVIEW OF THE COMPLAINT DATABASE INDICATED THAT THIS IS THE FIRST REPORTED INCIDENT OF THIS NATURE FOR THIS DEVICE. THE INCIDENT REPORT NOTED THAT THE CATHETER WAS IMPLANTED AND FUNCTIONED WITHOUT INCIDENT FOR LONGER THAN THREE YEARS. DUE TO THE LENGTH OF IMPLANTATION WE ARE UNABLE TO DETERMINE THE CAUSE OR FACTORS WHICH MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "LUER LOCK END OF VENOUS EXTENSION SET CAME APART FROM ACTUAL BODY OF EXTENSION SET/LINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOFLEX TESIO CATHETER HEMODIALYSIS CATHETER MSD MEDCOMP UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention