BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAHURKAR

    MDR report key: 11797104 · Received May 7, 2021

    Report

    Report Number
    MW5101256
    Event Type
    Injury
    Date Received
    May 7, 2021
    Date of Event
    May 5, 2021
    Report Date
    May 5, 2021
    Manufacturer
    COVIDIEN LLC
    Product Code
    NIE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MAHURKAR ACUTE DUAL LUMEN 10F 15CM HD CATHETER (REF 8817145005) BROKE AT THE JUNCTION OF THE TUBING AND THE BLUE PORT JUST ABOVE THE CLAMP. BLOOD STARTED LEAKING WHILE CATHETER WAS IN USE, CATHETER REMOVED, AND CHILD PUT UNDER GENERAL ANESTHESIA TO HAVE PERMCATH PLACED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684817 MAHURKAR CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED NIE COVIDIEN LLC (REF 8817145005)

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening