BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD Q-SYTE LUER ACCESS DEVICE

    MDR report key: 1940929 · Received December 17, 2010

    Report

    Report Number
    9610847-2010-00044
    Event Type
    Other
    Date Received
    December 17, 2010
    Date of Event
    October 29, 2010
    Report Date
    November 16, 2010
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS NOT BEEN REC'D TO DATE; IF THE SAMPLE IS REC'D, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    DURING DIALYSIS, AIR BUBBLES IN CATHETER; CATHETER WAS A DOUBLE LUMEN CATHETER. THE AIR WENT TO THE MACHINE AND NOT TO THE PT. AFTER CHANGING THE BD Q-SYTE, THE PROBLEM WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD Q-SYTE LUER ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other