BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTERIAL CATHETER

    MDR report key: 6057 · Received July 16, 1993

    Report

    Report Number
    33194-1993-09001
    Event Type
    Injury
    Date Received
    July 16, 1993
    Date of Event
    April 20, 1993
    Report Date
    April 30, 1993
    Manufacturer
    BECTON DICKINSON, VASCULAR ACCESS
    Product Code
    DXG
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CAATHETER WAS INSERTED OVER THE WIRE TECHNIQUE WITHOUT A PROBLEM. THE PATIENT BEGAN TRASHING AROUND. THE SENSOR WAS REMOVED, THEN THE CATHETER WAS REMOVED. CATHETR REMOVAAL WAS NOT SMOOTH, AND THE HUB AND ONLY PART OF THE CATHETER CAME OUT. PRESSURE WAS IMMEIATELY APPLIED TO PREVENT TIP MIGRATION,A ND AN INCISION WAS MADE. THE ATHETER WAS REMOVED WITHOUT DIFFICULTY AND THREE SUTURES WERE REQUIRED. ON 4/21/93, PATIENT'S WRIST INCISION APPEARED TOBE CLEAN AND WITHOUT SIGNS OR SYMPTOMS OF INFECTIONINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTERIAL CATHETER DXG BECTON DICKINSON, VASCULAR ACCESS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention