BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DTX PLUS

    MDR report key: 1033020 · Received April 22, 2008

    Report

    Report Number
    8020616-2008-00021
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 4, 2008
    Manufacturer
    BECTON DICKINSON CRITICAL CARE SYSTEMS PTE LTD.
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B) (4)

    Description of Event or Problem · 1

    THE INTERFACE CABLE DISCONNECTED WITH DTX CONNECTOR BECAUSE IT BECAME LOOSE DURING USE. THE CUSTOMER HAD TO CHANGE THE PRODUCT TO A NEW ONE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK