BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRITICATH

    MDR report key: 1030438 · Received April 16, 2008

    Report

    Report Number
    8020616-2008-00019
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 2, 2008
    Manufacturer
    BECTON DICKINSON CRITICAL CARE SYSTEMS PTE LTD.
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS REC'D FOR INVESTIGATION ON 04/10/2008. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING TESTING THE BALLOON INFLATED WITHOUT A PROBLEM. AFTER INSERTION, THE BALLOON EVENTUALLY DEFLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRITICATH THERMODILUTION CATHETER DYG BECTON DICKINSON CRITICAL CARE SYSTEMS PTE LTD. NA 712030

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK