BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEOTREND-L SENSOR

    MDR report key: 380848 · Received March 6, 2002

    Report

    Report Number
    9612233-2002-00002
    Event Type
    Other
    Date Received
    March 6, 2002
    Date of Event
    December 11, 2001
    Report Date
    December 14, 2001
    Manufacturer
    DIAMETRICS MEDICAL LTD
    Product Code
    CCE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOUND BLOOD SQUIRTING FROM CRACKED HUB OF THE INDWELLING BLOOD GAS SENSOR THAT GOES INTO THE UAC. UAC CLAMPED AND SENSOR WITHDRAWN. PT CONDITION NOT DRASTICALLY CHANGED. RECCURRING PROBLEMS WITH CRACK NOTED IN LUER LOCK CONNECTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOTREND-L SENSOR BLOOD GAS MONITORING SYSTEM CCE DIAMETRICS MEDICAL LTD N7004L 813

    Patients

    Seq Age Sex Outcome Treatment
    1 11 DAY Other