BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARGON MEDICAL DEVICES

    MDR report key: 4945816 · Received July 23, 2015

    Report

    Report Number
    MW5044791
    Event Type
    Injury
    Date Received
    July 23, 2015
    Date of Event
    June 23, 2015
    Report Date
    July 9, 2015
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    FTN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD ARTERIAL LINE PLACED IN LEFT RADIAL IN THE OPERATING ROOM ON (B)(6) 2015, WHICH FUNCTIONAL UNEVENTFULLY DURING THE SURGICAL PROCEDURE. APPROX 4 HOURS POST-OPERATIVELY, THE WAVEFORM WAS NOTED TO BE FLAT, WITH NO BP READING. DRESSING WAS REMOVED, SUTURES INTACT. WHEN REMOVING THE ARTERIAL LINE, ONLY THE HUB CAME OUT. THE ACTUAL CATHETER WAS RETAINED IN THE PTS' WRIST. PT WAS TAKEN BACK TO SURGERY ON (B)(6) 2015 FOR REMOVAL OF THE RETAINED PORTION OF THE ARTERIAL LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477936 ARGON MEDICAL DEVICES ARTERIAL CATHETER MINI KIT FTN ARGON MEDICAL DEVICES, INC. 498107 11096177
    477937 ARGON MEDICAL DEVICES ARTERIAL CATHETER MINI KIT FTN ARGON MEDICAL DEVICES, INC. 498107 11098879
    477938 ARGON MEDICAL DEVICES ARTERIAL CATHETER MINI KIT FTN ARGON MEDICAL DEVICES, INC. 498107 11096973

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention