BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD Q-SYTE LUER ACCESS SPLIT SEPTUM

    MDR report key: 2355819 · Received November 22, 2011

    Report

    Report Number
    9610847-2011-00091
    Event Type
    Injury
    Date Received
    November 22, 2011
    Date of Event
    October 10, 2011
    Report Date
    November 22, 2011
    Manufacturer
    BECTON DICKSON INFUSION THERAPY SYSTEMS
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL SAMPLE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL, HOWEVER, AN UNUSED, REPRESENTATIVE UNIT WILL BE RETURNED. ADDITIONAL INFO REGARDING THIS INCIDENT HAS BEEN REQUESTED. UPON RECEIPT OF THE SAMPLE AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE B. BRAUN 3-WAY-TAP CONNECTOR ATTACHED TO THE BD Q-SYTE DEVICE DETACHED, RESULTING IN LEAKAGE OF CYTOTOXIC CHEMOTHERAPY AGENTS ONTO THE RECEIVING PT, HIS/HER CLOTHES, HOSPITAL LINES AND FLOOR. THIS PUT THE STAFF AT SIGNIFICANT RISK OF EXPOSURE TO SAID CYTOTOXIC MATERIAL. ACCORDING TO THE ACCOUNT MANAGER, IT SEEMS AS THOUGH A FIRM CONNECT BETWEEN THE B. BRAUN DEVICE AND BD Q-SYTE DEVICE COULD NOT BE VISUALLY CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD Q-SYTE LUER ACCESS SPLIT SEPTUM INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKSON INFUSION THERAPY SYSTEMS NA 1119702

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other CYTOTOXIC CHEMOTHERAPY AGENTS