BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASHIR ENDOVASCULAR CATHETER PLUS40

    MDR report key: 16689146 · Received April 5, 2023

    Report

    Report Number
    MW5116371
    Event Type
    Malfunction
    Date Received
    April 5, 2023
    Date of Event
    February 10, 2021
    Report Date
    March 29, 2023
    Manufacturer
    THROMBOLEX, INC.
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    BLEEDING OCCURRED WHEN WIRE LUMEN PORT BROKE WHILE PATIENT WAS BEING INFUSED. REF REPORT: MW5116370.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518791 BASHIR ENDOVASCULAR CATHETER PLUS40 CATHETER, CONTINUOUS FLUSH KRA THROMBOLEX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Other