BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1

    MDR report key: 11018932 · Received December 16, 2020

    Report

    Report Number
    3012307300-2020-12450
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Date of Event
    November 6, 2020
    Report Date
    January 18, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LGZ
    UDI-DI
    30695085407007
    PMA / PMN Number
    K911383
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: INVESTIGATION COMPLETED ON A SMITHS MEDICAL FLUID WARMING/LEVEL 1 HOTLINE DISPOSABLES . RECEIVED SEVEN PICTURES ON FLUID WARMING/LEVEL 1 HOTLINE DISPOSABLES PINHOLE DISCOVERED UPON INSPECTION AND SAMPLE P/N L-70; L/N: 3974842 WAS RECEIVED. PICTURES UPON VISUAL INSPECTION FORM DISTANCE OF 12"-24" REVEALED TUBE WAS DAMAGED. THE SAMPLE WAS TESTED AND DID NOT CONFIRM FAILURE MODE. REVIEWING ENGINEERING PRACTICE THE PRODUCT PASSED ALL TESTING 100% PRIOR TO LEAVING THE FACILITY AND THE CAUSE OF THE EVENT IS BELIEVED TO OF OCCURRED AFTER LEAVING THE MANUFACTURING SITE. NO FAULT COULD BE FOUND.

    Description of Event or Problem · 0

    INVESTIGATION COMPLETED AND SUMMARIZED IN H 10.

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OPERATOR IDENTIFIED A PINHOLE IN THE LEVEL 1 HOTLINE DISPOSABLE. THERE WAS NO PATIENT INVOLVEMENT. THE PRODUCT PROBLEM WAS OBSERVED DURING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488793 LEVEL 1 WARMER, THERMAL, INFUSION FLUID LGZ SMITHS MEDICAL ASD, INC. L-70 3974842 30695085407007

    Patients

    Seq Age Sex Outcome Treatment
    1