BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD Q-SYTE LUER ACCESS SPLIT SEPTUM

    MDR report key: 2033286 · Received March 16, 2011

    Report

    Report Number
    9610847-2011-00010
    Event Type
    Other
    Date Received
    March 16, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO REGARDING THIS INCIDENT HAS BEEN REQUESTED. THE SAMPLE MAY BE AVAILABLE FOR EVAL. IF ADD'L INFO IS REC'D AND/OR THE SAMPLE IS RETURNED FOR INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE MIC-KEY EXTENSION SET, BARD'S EXTENSION SET AND THE PURPLE CONNECTOR END OF THE KANGAROO PUMP SET WERE ACCIDENTLY CONNECTED TO THE BD Q-SYTE DEVICE ON A PREMATURE INFANT. THE DEVICES WERE ABLE TO BE INSERTED INTO THE BD Q-SYTE DEVICE WHEN THE INTENDED USE FOR DELIVERING ENTERAL FEEDING SOLUTION. THERE WAS NO HARM TO THE BABY AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD Q-SYTE LUER ACCESS SPLIT SEPTUM INTRAVASCULAR ADMINISTRATION SET FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other