BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUTRACLEAR NEEDLE-FREE CONNECTOR

    MDR report key: 8388456 · Received March 4, 2019

    Report

    Report Number
    9616066-2019-00582
    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 A LARGE NUMBER OF EVENTS FOR STICK DOWN AND LEAKS WITH THE NEEDLELESS VALVE WHICH OCCURRED IN THE ICU OVER A 6-7 WEEK PERIOD. THE FAILURE RATE OBSERVED FOR THIS PRODUCT WAS BETWEEN 30-40% IN ONE OF THEIR CARE UNITS. THIS WAS ESTIMATED TO BE APPROXIMATELY 400 FAILURES OBSERVED IN THE LAST 37 DAYS, HOWEVER THOSE FAILURES/EVENTS WERE NOT DOCUMENTED, TRACKED NOR REPORTED TO BD. THERE WAS NO PATIENT HARM REPORTED FROM THE STICK DOWN OR LEAK EVENTS. THE ASSISTANT MANAGER OF THE ICU REPORTED THAT THERE HAS NOT BEEN AN INCREASE IN THE HOSPITAL¿S (B)(6) INFECTION RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181022 NEUTRACLEAR NEEDLE-FREE CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA CAIR LGL EL-NC1001

    Patients

    Seq Age Sex Outcome Treatment
    1