BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD DTX PLUS

    MDR report key: 1172784 · Received September 17, 2008

    Report

    Report Number
    8020616-2008-00037
    Event Type
    Other
    Date Received
    September 17, 2008
    Report Date
    August 19, 2008
    Manufacturer
    BECTON DICKINSON CRITICAL CARE SYSTEMS PTE LTD.
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED. THE SAMPLE WAS RECEIVED ON 09/08/2008 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

    TWO ISSUES WITH PM KITS WHERE IV SET-SET TUBING HAS COME LOOSE FROM DRIP CHAMBER. IT JUST HAPPENED WITHOUT WARNING. THE KIT WAS PLACED IN THE ANESTHESIA AND THE PT WAS MOVED TO DEPARTMENT WHEN THE INCIDENT OCCURRED. NO PROBLEMS WERE NOTICED WHEN THE PRESSURE MONITORING KIT WAS PLACED.

    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