BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD

    MDR report key: 12210746 · Received July 22, 2021

    Report

    Report Number
    12210746
    Event Type
    Malfunction
    Date Received
    July 22, 2021
    Date of Event
    May 27, 2021
    Report Date
    May 28, 2021
    Manufacturer
    AVANOS MEDICAL, INC.
    Product Code
    NZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    STAFF ARE RECEIVING PACKAGES WHERE THE SEAL ON THE APPLICATOR IS BROKEN WITHIN THE PACKAGE AND LEAKS OUT/CONTAMINATED OR THE SEAL WON'T BREAK IN ORDER TO DISPENSE/RELEASE THE SEALANT. DEFECTIVE SAMPLES AND PACKAGING NOT SAVED. REQUESTED STAFF TO SAVE IN THE FUTURE FOR REPORTING AND TRACKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1106189 HALYARD SEALANT, MICROBIAL NZP AVANOS MEDICAL, INC. 33737

    Patients

    Seq Age Sex Outcome Treatment
    1