BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD Q-SYTE LUER ACCESS SPLIT SEPTUM

    MDR report key: 2108679 · Received May 9, 2011

    Report

    Report Number
    9610847-2011-00030
    Event Type
    Other
    Date Received
    May 9, 2011
    Date of Event
    April 23, 2011
    Report Date
    May 9, 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 SAMPLES ARE AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION 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 CHILD WAS RE-ADMITTED TO THE HOSPITAL FROM HOME SOLUTIONS HOME CARE WITH DAMAGED BD Q-SYTE DEVICES. THE SEPTUMS WERE LEAKING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other