BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q2 SWABSITE SWABABLE NEEDLELESS CONNECTOR

    MDR report key: 5612494 · Received April 27, 2016

    Report

    Report Number
    1649914-2016-00019
    Event Type
    Malfunction
    Date Received
    April 27, 2016
    Date of Event
    March 25, 2016
    Report Date
    March 29, 2016
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K002689
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    QUEST MEDICAL, INC. HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC. DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PRODUCT DISTRIBUTOR NOTIFIED THE MANUFACTURER OF AN ISSUE ENCOUNTERED WITH THE Q2 SWABABLE NEEDLELESS CONNECTOR DURING USE AT A HOSPITAL. THE REPORT STATED THAT THE ALLEGED EVENT OCCURRED WITH A NEW USER AT A FACILITY UNDERGOING AN EVALUATION OF THE DEVICE FOR USE IN HEMODIALYSIS. THE COMPLAINANT REPORTED BLOOD REFLUX WHERE THE DEVICE (AN ADAPTER) IS CONNECTED TO THE HEMODIALYSIS CATHETER. THE DEVICE WAS NOT RETURNED TO THE DISTRIBUTOR NOR THE MANUFACTURER FOR EVALUATION. THE DEVICE WAS USED IN AN OFF-LABEL INDICATION FOR HEMODIALYSIS. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268529 Q2 SWABSITE SWABABLE NEEDLELESS CONNECTOR NEEDLELESS CONNECTOR FPA QUEST MEDICAL, INC. 3150 492545E05

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention