BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEOTREND-L SENSOR

    MDR report key: 525148 · Received February 12, 2004

    Report

    Report Number
    9612233-2004-00002
    Event Type
    Other
    Date Received
    February 12, 2004
    Date of Event
    January 1, 2004
    Report Date
    January 12, 2004
    Manufacturer
    DIAMETRICS MEDICAL, LTD.
    Product Code
    CCE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER WAS UNABLE TO INSERT THE NEOTREND-L SENSOR INTO THE UMBILICAL ARTERY CATHETER (UAC). WHILE ATTEMPTING TO INSERT THE SENSOR, BLOOD LEAKED BACK UP INSIDE THE SENSOR AND LEAKED INSIDE THE SENSOR AND LEAKED OUT AT THE ADVANCEMENT LOCK. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOTREND-L SENSOR BLOOD GAS MONITORING SYSTEM CCE DIAMETRICS MEDICAL, LTD. N7004L 876

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN