BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPUNCTURE INTRODUCER SET

    MDR report key: 12682382 · Received October 21, 2021

    Report

    Report Number
    MW5104896
    Event Type
    Injury
    Date Received
    October 21, 2021
    Date of Event
    October 19, 2021
    Report Date
    October 20, 2021
    Manufacturer
    COOK INCORPORATED
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A TUNNELED HEMODIALYSIS CATHETER INSERTION, THE HUB OF A MICROPUNCTURE BROKE OFF AND THE CATHETER BECAME A FOREIGN OBJECT IN THE PT'S RIGHT INTERNAL JUGULAR VEIN. THE CATHETER WAS RETRIEVED VIA THE RIGHT FEMORAL VEIN WITH THE AID OF A SNARE AND REMOVED. ENTIRE PIECE SUCCESSFULLY REMOVED. ASSESSMENT - NON OLIGURIC AKI ON CKD VERSUS CKD PROGRESSION, LIKELY PROGRESSING TO ESRD-HTN UNCONTROLLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567760 MICROPUNCTURE INTRODUCER SET COOK MEDICAL INTRODUCER, CATHETER DYB COOK INCORPORATED G43869 14207074

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention