BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD INTERLINK

    MDR report key: 1416331 · Received July 15, 2009

    Report

    Report Number
    2618282-2009-00010
    Event Type
    Other
    Date Received
    July 15, 2009
    Date of Event
    May 14, 2009
    Report Date
    June 18, 2009
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FGY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RECEIVED ON (B)(4) 2009 AND IS CURRENTLY BEING DECONTAMINATED. UPON DECONTAMINATION AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    A NURSE WAS CHANGING LINES ON A VASOACTIVE INFUSION. SHE USED A NEEDLELESS ACCESS DEVICE USED BY THE HOSPITAL. AFTER MAKING THE CHANGE, THE PT WAS NOTED TO HAVE A PRECIPITOUS DROP IN BLOOD PRESSURE AND HEART RATE. THE NURSE THEN NOTED THAT THERE WAS LEAKING AT THE SITE OF THE NEEDLELESS ACCESS. UPON FURTHER INVESTIGATION SHE FOUND THAT THE ACCESS DEVICE WHILE APPEARING INTACT AND SCREWING ON TO THE NEEDLESS PORT, WAS ACTUALLY BROKEN OFF AND NEVER MADE ACCESS TO THE NEEDLELESS CAP. THUS, THE PT WAS NOT RECEIVING ANY OF THE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD INTERLINK THREADED LOCK CANNULA FGY BECTON DICKINSON INFUSION THERAPY SYSTEMS NA 8079651

    Patients

    Seq Age Sex Outcome Treatment
    1 3.5 MO Other