BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AC CIRCLE CATHETERS 23CM X 13.5CM

    MDR report key: 344473 · Received August 1, 2001

    Report

    Report Number
    344473
    Event Type
    Injury
    Date Received
    August 1, 2001
    Date of Event
    July 13, 2001
    Report Date
    July 25, 2001
    Manufacturer
    NEO-STAR MEDICAL TECHNOLOGIES
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED TO SPECIAL PROCEDURES FOR FIBRIN STRIPPING OF PERMACATH. STRIPPING PROCEEDED WITHOUT DIFFICULTY. WHEN CHEST FLUROED FOR PNEUMOTHORAX, THE FLURO REVEALED THE DISTAL END OF THE LONGER ASPECT OF CATHETER TO BE FRACTURED FROM THE END OF THE CATHETER. RETRIEVAL OF THE LOOSE CATHETER PIECE WAS PERFORMED WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34536 AC CIRCLE CATHETERS 23CM X 13.5CM PERMACATH FJS NEO-STAR MEDICAL TECHNOLOGIES * SE98221

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention