BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NRFIT CONNECTOR

    MDR report key: 19656154 · Received July 2, 2024

    Report

    Report Number
    3012307300-2024-05724
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    May 27, 2024
    Report Date
    August 22, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LHI
    UDI-DI
    10610586044113
    PMA / PMN Number
    K162219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    ONE SAMPLE WAS RETURNED FOR EVALUATION. NOTE: IN THE EVENT DESCRIPTION MENTIONED THE PART NUMBER: 21-7605-24 AND THAT NUMBER DOES NOT BELONG TO THE LOT NUMBER REPORTED AND THE SAMPLE RECEIVED. THE COMPLAINT SAMPLE WAS VISUALLY INSPECTED, AT 12¿ TO 16¿ UNDER NORMAL CONDITIONS OF ILLUMINATION. THE SAMPLE RETURNED WAS TESTED USING THE HYDROSTATIC VESSEL, AND DISTILLATED WATER, TO VERIFY THE CORRECT FUNCTIONALITY OF THE SAMPLE. DURING THE TEST THE LIQUID DOES NOT THROUGH FOR THE DEVICE, AN OCCLUSION WAS DETECTED. ACCORDING TO THE VISUAL AND FUNCTIONAL TEST, THE FAILURE MODE REPORTED IN THE COMPLAINT, OCCLUDED/BLOCKAGE, WAS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A BLOCKAGE DURING LIQUID DELIVERY. PER REPORTER, THE PROBLEM WAS RESOLVED BY REPLACING THE TUBE AND THIS EVENT OCCURRED DURING PATIENT USE/ADMINISTRATION. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601859 NRFIT CONNECTOR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4376901 10610586044113

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown