BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DTX PLUS

    MDR report key: 1250880 · Received December 2, 2008

    Report

    Report Number
    8020616-2008-00043
    Event Type
    Malfunction
    Date Received
    December 2, 2008
    Date of Event
    November 15, 2008
    Report Date
    November 17, 2008
    Manufacturer
    BECTON DICKINSON CRITICAL CARE SYSTEMS PTE LTD.
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RECEIVED ON 25 NOVEMBER 2008 AND IS CURRENTLY BEING INVESTIGATED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B) (4). (B) (4).

    Description of Event or Problem · 1

    TUBE DETACHED FROM THE BOTTOM OF ADSET CHAMBER. THE UNIT WAS STARTED ON 11/14/2008 AND DETACHED ON (B) (6) 2008 WHILE THE PT WAS IN THE ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD DTX PLUS DISPOSABLE PRESSURE TRANSDUCER WITH PRESSURE MONITORING SET DRS BECTON DICKINSON CRITICAL CARE SYSTEMS PTE LTD. NA 710572

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK