BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITAN CATHETER

    MDR report key: 9278449 · Received November 5, 2019

    Report

    Report Number
    2518902-2019-00067
    Event Type
    Malfunction
    Date Received
    November 5, 2019
    Report Date
    November 5, 2019
    Manufacturer
    MEDICAL COMPONENTS, INC.
    Product Code
    MSD
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE INCIDENT WAS NOT RETURNED FOR EVALUATION. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE INCIDENT AND THE DEVICE WERE UNSUCCESSFUL. WITHOUT SUFFICIENT INFORMATION, OR AN EVALUATION OF THE DEVICE INVOLVED, WE ARE UNABLE TO DETERMINE THE CAUSE OR FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. TRENDING WAS PERFORMED FOR 5 YEARS (11/05/2014 TO 11/05/2019) USING CRITERIA: PRODUCT FAMILY-LIKE "THD"; INCIDENT CODE-LU-4, LUER/S - LEAKING. 1 COMPLAINT WAS IDENTIFIED. RISK ASSESSMENT DOCUMENTATION REVIEWED, FAILURE MODE IS COVERED, NO NEW RISKS WERE IDENTIFIED. RMA-16002-001, LONG TERM HEMODIALYSIS CATHETERS, REV. A LINES 10-90, 180-200, 2290-2320, 2990, 3000-3010, 3880-3890.

    Description of Event or Problem · 1

    THE VENOUS PORT ON THE TITAN CATHETER WAS LEAKING. PATIENT REPORTED TO HAVE LOST MORE THAN 100CC OF BLOOD. CATHETER WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074098 TITAN CATHETER HEMODIALYSIS CATHETER MSD MEDICAL COMPONENTS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR