BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1

    MDR report key: 10935441 · Received December 2, 2020

    Report

    Report Number
    3012307300-2020-12002
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    October 27, 2020
    Report Date
    February 16, 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
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: INVESTIGATION COMPLETED ON A SMITHS MEDICAL FLUID WARMING/LEVEL 1 HOTLINE DISPOSABLES. SAMPLE RECEIVED P/N L-70; L/N: 3942949 . WHEN TESTING WITH SYRINGE TO REPLICATE THE EVENT THE SAMPLE DID NOT LEAK. THE PRODUCTION WAS REVIEWED, WHICH REVEALED FUNCTIONING 100% PRIOR TO RELEASE OF PRODUCT WITH ALL FUNCTIONAL TESTING. NO FAULT COULD BE FOUND AS EVENT WAS NOT DUPLICATED.

    Description of Event or Problem · 0

    INVESTIGATION COMPLETED AND SUMMARY IN H 10.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL DEVICE HAD A LEAK IN TUBING WHILE SETTING UP THE TUBING. THERE WERE NO REPORTED ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1401042 LEVEL 1 FLUID WARMER LGZ SMITHS MEDICAL ASD, INC. L-70 3942949 30695085407007

    Patients

    Seq Age Sex Outcome Treatment
    1