BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEOTREND-L SENSOR

    MDR report key: 527206 · Received February 19, 2004

    Report

    Report Number
    9612233-2004-00003
    Event Type
    Other
    Date Received
    February 19, 2004
    Date of Event
    January 1, 2004
    Report Date
    January 22, 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 USER WAS UNABLE TO INSERT THE NEOTREND-L SENSOR INTO THE UMBILICAL ARTERY CATHETER (UAC). WHILST ATTEMPTING THE INSERTION, THE SENSOR WAS RETRACTED THROUGH THE Y-PIECE SEAL AND BLOOD LEAKED BACK UP INSIDE THE SENSOR. NO HARM OR INJURY TO THE PT 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 896

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN