BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERICARE SOLUTIONS

    MDR report key: 17975349 · Received October 20, 2023

    Report

    Report Number
    17975349
    Event Type
    Malfunction
    Date Received
    October 20, 2023
    Date of Event
    June 8, 2023
    Report Date
    September 25, 2023
    Manufacturer
    NURSE ASSIST, LLC.
    Product Code
    FRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RN WAS ABOUT TO ADMINISTER 500ML STERILE WATER (ITEM #6290) ONTO A STERILE BACKTABLE FOR SURGERY AND NOTED THAT THE SEAL WAS DISCOLORED (YELLOW/COPPER) WITH A BUBBLED APPEARANCE. THE PAPER PORTION OF THE SEAL WAS DAMAGED BY FLUID AND THE FOIL WAS NOT FULLY INTACT. LOT #23045424.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209916 STERICARE SOLUTIONS DRESSING, WOUND, DRUG FRO NURSE ASSIST, LLC. 6290 23045424

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown