BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD Q-SYTE LUER ACCESS SPLIT SEPTUM

    MDR report key: 2108173 · Received May 12, 2011

    Report

    Report Number
    9610847-2011-00031
    Event Type
    Other
    Date Received
    May 12, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 11, 2011
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL SAMPLE INVOLVED IN THE INCIDENT IS NOT AVAILABLE FOR EVALUATION, HOWEVER, REPRESENTATIVE UNITS FROM MULTIPLE LOT NUMBERS WILL BE RETURNED. 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 PATIENT WAS ON HOME INFUSIONAL 5 FU WITH A BD Q-SYTE ATTACHED TO THE PORT TUBING, AND A PUMP CASSETTE ATTACHED TO THE BD Q-SYTE DEVICE. THE PATIENT RETURNED TO THE HOSPITAL WITH A BD Q-SYTE DEVICE THAT WAS LEAKING CHEMOTHERAPY DRUGS.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other