BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD Q-SYTE LUER ACCESS SPLIT SYSTEM

    MDR report key: 3894084 · Received June 19, 2014

    Report

    Report Number
    2243072-2014-00130
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    January 1, 2014
    Report Date
    June 18, 2014
    Manufacturer
    BD
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS AVAILABLE FOR EVALUATION. UPON RECEIPT OF THE SAMPLE AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT'S BD Q-SYTE BROKE DURING THE CHANGING OF INFUSION, LINES AND BD Q-SYTE DEVICES, LEAVING THE MALE CONNECTOR IN THE FEMALE PART OF THE SKIN TUNNELLED LINE. THE PATIENT HAD TO ATTEND A & E AS AN EMERGENCY AS THE HAL-LIFE OF THE DRUG THAT WAS BEING CONTINUOUSLY INFUSED IS 3-5 MINUTES WITH A HIGH RISK OF CARDIOVASCULAR COLLAPSE IF IT IS INTERRUPTED. THE TEAM WAS ABLE TO REMOVE THE BROKEN PORTION OF THE BD Q-SYTE DEVICE THAT HAD LODGED IN THE GROSHONG LINE CONNECTOR SO THAT INFUSION COULD BE RECOMMENCED. A WEEK LATER, THE PATIENT RETURNED TO A & E AS THE CONNECTOR OF THE GROSHONG LINE WAS LEAKING DUE TO A FRACTURE. THE FRACTURE WAS LIKELY THE RESULT OF THE ATTEMPTS TO REMOVE THE BROKEN PORTION OF THE BD Q-SYTE DEVICE. THE GROSHONG LINE WAS THEN REPAIRED, CAUSING DISTRESS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362132 BD Q-SYTE LUER ACCESS SPLIT SYSTEM NEEDLESS IV CONNECTOR FOZ BD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention