BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEOTREND SENSOR

    MDR report key: 245442 · Received October 15, 1999

    Report

    Report Number
    9612233-1999-00018
    Event Type
    Other
    Date Received
    October 15, 1999
    Date of Event
    September 16, 1999
    Report Date
    September 17, 1999
    Manufacturer
    DIAMETRICS MEDICAL LTD
    Product Code
    CCE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE HOSPTIAL REPORTED DIFFICULTY IN INSERTING A NEOTREND SENSOR (LOT# 706-022) AND CONSEQUENTLY, SOME BLOOD LEAKAGE REPORTEDLY OCCURRED AT THE REAR CLAMP OF THE DEVICE. NO INJURY TO THE PATIENT HAS BEEN REPORTED. A FULL INVESTIGATION WILL BE PERFORMED ONCE THE DEVICE HAS BEEN RETURNED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOTREND SENSOR BLOOD GAS MONITORING SYSTEM CCE DIAMETRICS MEDICAL LTD N7004S 706-022

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN