BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD NKA BECTON DICKINSON AND COMPANY

    MDR report key: 9672069 · Received January 29, 2020

    Report

    Report Number
    9672069
    Event Type
    Injury
    Date Received
    January 29, 2020
    Date of Event
    January 20, 2020
    Report Date
    January 28, 2020
    Manufacturer
    BARD NKA BECTON DICKINSON AND COMPANY
    Product Code
    NIE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DR WAS PLACING HD CATH ON PT. UPON REMOVAL OF A GUIDE WIRE THE INNER PART OF WIRE WAS REMOVED WHILE THE OUTER COIL PEELED AWAY AND APPARENTLY BROKE OFF INSIDE OF PT. THIS WAS VISUALIZED ON POST LINE CHEST X-RAY. THE ORIGINAL CATHETER INITIALLY GAVE BLOOD RETURN BUT AFTER PLACEMENT THERE WAS NO BLOOD RETURN. THIS CATHETER WAS REMOVED AND ANOTHER WAS INSERTED WITHOUT ISSUE. REPEAT X-RAY STILL SHOWED WIRE SO A CT SCAN OF CHEST WAS DONE AND PT WAS SCHEDULED TO GO TO CATH LAB FOR REMOVAL OF WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108337 BARD NKA BECTON DICKINSON AND COMPANY POWER-TRIALYSIS NIE BARD NKA BECTON DICKINSON AND COMPANY 5613120 REDP1857

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention