BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD INTERLINK

    MDR report key: 1060722 · Received June 12, 2008

    Report

    Report Number
    2618282-2008-00004
    Event Type
    Other
    Date Received
    June 12, 2008
    Date of Event
    May 16, 2008
    Report Date
    May 26, 2008
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PATIENT WAS RECEIVING CHEMOTHERAPY VIA AN AMBULATORY PUMP AT HOME, WHERE THE ATTACHED THREADED LOCK CANNULA PRODUCT BECAME DISCONNECTED. THIS RESULTED IN A CHEMO SPILL AT HOME. THE PHYSICIAN WAS NOTIFIED AND NO DOSING WAS ADJUSTED BASED ON THE SPILL. CONCERN THE CONNECTION DID NOT LOCK INTO PLACE, THIS INCIDENT HAPPENED WHILE THE PT WAS SLEEPING AND WOKE UP FROM A WET SENSATION ON CLOTHING. THE PT HAS BEEN INSTRUCTED TO CHECK CONNECTIONS MORE OFTEN AND TO USE TAPE IF NEEDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other CHEMOTHERAPY