BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD Q-SYTE: IER ACCESS DEVICE

    MDR report key: 1632755 · Received February 5, 2010

    Report

    Report Number
    9610847-2009-00094
    Event Type
    Other
    Date Received
    February 5, 2010
    Date of Event
    November 17, 2009
    Report Date
    November 18, 2009
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS BEEN RECEIVED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    PT WAS IN CT SCAN RECEIVING CONTRAST MEDIA VIA 20 GAUGE CATHETER AND A BD Q-SYTE EXTENSION SET. THE CONTRAST WAS BEING INJECTED AT APPROX 3-4 CC/SECOND AND THE TUBING SPLIT OPEN LENGTHWISE. BLOOD OOZED OUT AND THE CATHETER REMAINED IN PLACE. THE DEFECTIVE TUBING WAS REMOVED AND REPLACED WITH A NEW EXTENSION SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD Q-SYTE: IER ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS NA 9244081

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other