BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUTRACLEAR NEEDLE-FREE CONNECTOR

    MDR report key: 8388432 · Received March 4, 2019

    Report

    Report Number
    9616066-2019-00563
    Event Type
    Malfunction
    Date Received
    March 4, 2019
    Report Date
    February 4, 2019
    Manufacturer
    CAIR LGL
    Product Code
    FPA
    PMA / PMN Number
    K171117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS NOT SEQUESTERED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN EVENT OCCURRED WHERE THE PATIENT HAD AN ARTERIAL LINE WITH A 3 WAY STOPCOCK AND THE NURSE FOUND AIR IN THE ARTERIAL LINE TUBING AND WAS ALSO LOSING PRESSURE IN THE TUBING. TROUBLESHOOTING REVEALED THAT A STICK DOWN OF THE NEEDLELESS VALVE RESULTED IN AIR ENTERING THE ARTERIAL LINE TUBING. THE NEEDLELESS VALVE WAS CHANGED AND NO PATIENT HARM OCCURRED. EVENT DATE: BETWEEN (B)(6) 2018 AND (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180709 NEUTRACLEAR NEEDLE-FREE CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA CAIR LGL EL-NC1001

    Patients

    Seq Age Sex Outcome Treatment
    1