BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 HOTLINE FLUID WARMING SET

    MDR report key: 13349095 · Received January 25, 2022

    Report

    Report Number
    3012307300-2022-01694
    Event Type
    Malfunction
    Date Received
    January 25, 2022
    Report Date
    June 9, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LGZ
    UDI-DI
    30695085407007
    PMA / PMN Number
    K001764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. PICTURES ATTACHED: AS PART OF INVESTIGATION IN-0130211 TWO IMAGES WERE PROVIDED. VISUAL INSPECTION RESULTS BASED ON PICTURE: BASED ON IMAGE PROVIDED, LEAKAGE CAN?T BE CONFIRMED., ONLY CAN BE NOTICEABLE A CRACKING ON LUER LOCK ADAPTER FEMALE P/N 00-208, THIS CONDITION COULD CAUSE LEAKAGE OR ANOTHER FUNCTIONAL FAILURE ON THE PRODUCT. THEREFORE, FAILURE MODE CAN BE CONFIRMED. SAMPLES RECEIVED: ONE (1) SAMPLE UNIT WERE RECEIVED AT SMITHS MTIJ WITH ITS ORIGINAL PACKAGE OPENED FROM P/N L-70 WITH LOT NUMBER 4143680 REPORTED IN COMPLAINT. VISUAL INSPECTION: THE SAMPLES WERE VISUALLY INSPECTED AT A DISTANCE OF 12? UNDER NORMAL LIGHTING TO RECEIVED UNIT, SEE IMAGES BELOW. RESULTS FOR VISUAL INSPECTION IN SAMPLE PROVIDED: NO MARKS OR STAINS WERE OBSERVED ON TUBE SURFACE, NEITHER ON REFLUX CONNECTOR OR SWIVEL CONNECTOR. IT WAS OBSERVED A CRACKING ON LUER LOCK ADAPTER FEMALE P/N 00-208, THIS COSMETIC ISSUE COULD CAUSE LEAKAGE OR ANOTHER FUNCTIONAL FAIL TEST. THEREFORE, FAILURE MODE CAN BE CONFIRMED. RESULTS FOR FUNCTIONAL TEST IN SAMPLE PROVIDED: BASED ON MANUFACTURING PROCEDURE MP L-70 REV.117 AND FAILURE MODE REPORTED, WE PERFORMED A LEAKAGE TEST ON SAMPLE PROVIDED, IN ORDER TO VERIFY IF LEAKAGE CAN BE CONFIRMED WHICH CAN BE CAUSED BY CRACKING ON LUER CONNECTOR DETECTED PREVIOUSLY IN VISUAL INSPECTION, AFTER TEST WAS PERFORMED TO THE PIECE, SAMPLES DOESN?T PASS SUCCESSFULLY LEAKAGE TEST. CONCLUSIONS: BASED ON THE LEAK TEST RESULTS, THE REPORTED NONCONFORMANCE IS CONFIRMED. BASED ON THE SAMPLE PROVIDED, ANALYSIS CONDUCTED ON PHYSICALLY EVALUATION, TREND ANALYSIS FOR THIS FAILURE MODE IN COMPLAINTS, ROOT CAUSE CAN BE DETERMINED AS SUPPLIER ITEM FAULT. THE CAUSE OF THE REPORTED PROBLEM WAS TRACED TO THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DEVICE WAS BEING CHECKED PRIOR TO USE AND FOUND TO HAVE A DAMAGED LUER LOCK. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702482 LEVEL 1 HOTLINE FLUID WARMING SET WARMER, THERMAL, INFUSION FLUID LGZ SMITHS MEDICAL ASD, INC. L-70 4143680 30695085407007

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown