BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD Q-SYTE LUER ACCESS SPLIT SEPTUM

    MDR report key: 2142293 · Received June 17, 2011

    Report

    Report Number
    9610847-2011-00042
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 17, 2011
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION REGARDING THIS INCIDENT HAVE BEEN MADE. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE BD Q-SYTE INSTRUCTIONS FOR USE STATE IT IS RECOMMENDED THAT THE DEVICE BE CHANGED ACCORDING TO FACILITY POLICY, CDC (USA) GUIDELINES, OR IF THE INTEGRITY OF THE DEVICE HAS BEEN COMPROMISED. DO NOT EXCEED 100 ACTUATIONS OF THE LUER ACCESS SPLIT SEPTUM DEVICE. (B)(4).

    Description of Event or Problem · 1

    AFTER BLOOD WAS DRAWN FROM THE CV, THE SYRINGE WAS REMOVED AND THE RUBBER SEPTUM OF THE BD Q-SYTE CAME OUT OF THE BD Q-SYTE HOUSING, RESULTING IN LEAKAGE. THE LINE WAS IMMEDIATELY CLAMPED. AFTER THE DAMAGE/LEAKAGE WAS FOUND AT 7:20AM, THE PATIENT COMPLAINED OF RESPIRATORY DISCOMFORT. AT 7:31AM, THE PATIENT'S PO2 DROPPED TO 84. BLOOD PRESSURE DROPPED TO 87/61. WHILE AN O2 INHALER WAS BEING PREPARED, SPO2 RECOVERED TO 99. AT 07:33AM, THE LEVEL OF SPO2 RECOVERED BUT THE PATIENT KEPT CLAIMING SUFFOCATION. O2 3ML WAS STARTED. AT 7:45AM, THE PATIENT WAS ABLE TO SPEAK BUT IT SEEMED TO BE DIFFICULT. AN X-RAY ON THE CHEST WAS TAKEN AND CONFIRMED NO ABNORMALITIES. THE BD Q-SYTE DEVICE HAD BEEN ACCESSED MORE THAN 50 TIMES IN 20 DAYS. THE BD Q-SYTE DEVICE WAS NOT CHANGED PERIODICALLY.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other