BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEOTREND-L SENSOR

    MDR report key: 492192 · Received October 21, 2003

    Report

    Report Number
    9612233-2003-00018
    Event Type
    Other
    Date Received
    October 21, 2003
    Date of Event
    September 13, 2003
    Report Date
    September 30, 2003
    Manufacturer
    DIAMETRICS MEDICAL, LTD.
    Product Code
    CCE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TO INSERT THE NEOTREND-L SENSOR INTO A 5.0FR CATHETER. THE SENSOR WOULD NOT ADVANCE AT ALL. BLOOD LEAKED OUT FROM THE ADVANCEMENT LOCK. THE SENSOR WAS REMOVED AND RETURNED TO THE MANUFACTURER FOR INVESTIGATION. NO REPORT OF INJURY OR HARM TO THE PATIENT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOTREND-L SENSOR BLOOD GAS MONITORING SYSTEM CCE DIAMETRICS MEDICAL, LTD. N7004L 884

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN