BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACIC SILICONE CATHETER

    MDR report key: 7632334 · Received June 22, 2018

    Report

    Report Number
    7632334
    Event Type
    Malfunction
    Date Received
    June 22, 2018
    Date of Event
    October 27, 2017
    Report Date
    October 27, 2017
    Manufacturer
    AXIOM MEDICAL, INC.
    Product Code
    GBX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE THORACIC SILICONE CATHETER WAS OPENED AND FOUND TO HAVE A CRUNCHY TEXTURE AND THE COATING WAS VISIBLY FLAKING OFF. THE STAFF NOTICED THIS BEFORE IT WAS USED. THEY OPENED THREE AND THEY WERE ALL FOUND TO HAVE THE SAME FLAKY COATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474522 THORACIC SILICONE CATHETER CATHETER, IRRIGATION GBX AXIOM MEDICAL, INC. 1706361

    Patients

    Seq Age Sex Outcome Treatment
    1