BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD Q-SYTE LUER ACCESS SPLIT SEPTUM WITH MICROBORE EXTENSION SET

    MDR report key: 2132526 · Received June 8, 2011

    Report

    Report Number
    9610847-2011-00040
    Event Type
    Injury
    Date Received
    June 8, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 8, 2011
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS AVAILABLE FOR EVALUATION. A REQUEST FOR ADDITIONAL INFORMATION REGARDING THIS INCIDENT HAS BEEN MADE. UPON RECEIPT OF THE SAMPLE AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. INTERNAL FILE NUMBER: (B)(4). DATE SUBMITTED: (B)(4) 2011.

    Description of Event or Problem · 1

    ONE OF THE NURSES IN THE (B)(6) DEPARTMENT EXPERIENCED LEAKING WHEN RUNNING CHEMOTHERAPY DRUGS THROUGH THE (B)(4) PRODUCT. THE NURSE DISCONNECTED THE CHEMOTHERAPY AND RAN SALINE THROUGH THE LINE. AT THIS TIME, IT WAS DISCOVERED THAT THE DEVICE LEAKED AT THE LUER CONNECTION TO THE BD Q-SYTE DEVICE ON THE EXTENSION SET HUB. THE LEAKAGE WAS NOT CRITICAL TO THE PT AND THERE WERE NO ADVERSE EFFECTS. THE ESTIMATED LEAKAGE WAS APPROXIMATELY 5CC OF CHEMOTHERAPY DRUGS. HOWEVER, THERE WAS SLIGHT BLOOD LOSS FOR THE PT DUE TO BACKFLOW FROM REDUCED PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD Q-SYTE LUER ACCESS SPLIT SEPTUM WITH MICROBORE EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS NA 1060826

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other RITUXIMAB