BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN HD OR HEMOFLOW TUNNELED DIALYSIS CATHETER

    MDR report key: 13026089 · Received December 16, 2021

    Report

    Report Number
    MW5106139
    Event Type
    Injury
    Date Received
    December 16, 2021
    Date of Event
    December 13, 2021
    Report Date
    December 15, 2021
    Manufacturer
    MEDCOMP / MEDICAL COMPONENTS INC
    Product Code
    MPB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MEDCOMP 15.5F STEP-TIP DIALYSIS CATHETER BROKE AT OUTSIDE FREE-STANDING CENTER WHILE THEY WERE TRYING TO REMOVE IT. HAD BEEN IN PLACE 2 YEARS 9 MONTHS. TIP BROKE OFF AND MIGRATED TO LEFT PULMONARY ARTERY. PROCEDURE ABORTED AND PT SENT HERE. REMOVED THE TIP FROM LEFT PA AND REPLACED "STUCK" CATHETER. NO SEQUELAE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1921616 TITAN HD OR HEMOFLOW TUNNELED DIALYSIS CATHETER CATHETER, HEMODIALYSIS, NON-IMPLANTED MPB MEDCOMP / MEDICAL COMPONENTS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Hospitalization| R