BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD Q-SYTE LUER ACCESS SPLIT SEPTUM

    MDR report key: 1979196 · Received January 26, 2011

    Report

    Report Number
    1710034-2011-00002
    Event Type
    Other
    Date Received
    January 26, 2011
    Date of Event
    December 27, 2010
    Report Date
    December 27, 2010
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED REGARDING THIS INCIDENT. UPON RECEIPT OF THE SAMPLE AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, INSERTED CV CATHETER WITH FGM EXT SET 2 BD Q-SYTE SC, LOCK, 20CM STD CONNECTED WITH FGM IV SET 60DROP 1SC, 200/50CM STD INTO THE PT'S FEMORAL AREA. ON (B)(6) 2010, CONNECTED JMS ADSET WITH BD Q-SYTE OF FGM IV SET 60DROP 1SC, 200/50CM STD AND BOUND THE CONNECTION AREA BETWEEN THE 3-WAY STOPCOCK AND KNOB OF THE JMS ADSET MALE LUER WITH A RUBBER BAND. WHEN DOSING ANTIBIOTIC THROUGH THE JMS ADSET, AIR WAS FOUND INSIDE THE LINE. AN ECHOCARDIOGRAPHY WAS PERFORMED ON THE PT AND AIR WAS CONFIRMED IN THE HEART. THE PT IS IN STABLE CONDITION.

    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 9350599

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other