BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD Q-SYTE LUER ACCESS SPLIT SEPTUM

    MDR report key: 2033285 · Received March 16, 2011

    Report

    Report Number
    9610847-2011-00008
    Event Type
    Other
    Date Received
    March 16, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 22, 2011
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS REC'D ON (B)(6) 2011 AND IS CURRENTLY BEING DECONTAMINATED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE BD Q-SYTE WAS PLACED ON (B)(6) 2011. ONE DAY LATER, THE CLINICIAN FOUND THE PT'S BED AND CLOTHING WERE WET. THERE HAD BEEN LEAKAGE OF HIGH CALORIE SOLUTION BETWEEN THE BD Q-SYTE DEVICE AND THE INFUSION SET. THE CLINICIAN THEN FLUSHED THE DEVICE WITH HEPARINIZED SALINE TO CONFIRM BLEED BACK, AND AIR WAS INTRODUCED. THE CLINICIAN CHANGED THE BD Q-SYTE DEVICE AND NO HARM TO THE PT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD Q-SYTE LUER ACCESS SPLIT SEPTUM INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS NA 0070942

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other