BEUDAMED
    FDA Adverse Event Other Summary report: N

    0.9% SODIUM CHLORIDE IRRIGATION USP

    MDR report key: 18191688 · Received November 21, 2023

    Report

    Report Number
    MW5148358
    Event Type
    Other
    Date Received
    November 21, 2023
    Report Date
    November 16, 2023
    Manufacturer
    NURSE ASSIST, LLC.
    Product Code
    NGT
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE REPORTER STATES THAT THEY ORDERED AND USED 0.9% SODIUM CHLORIDE IRRIGATION USP (STERICARE SOLUTIONS) MADE BY NURSE ASSIST, INC ON A PATIENT BEGINNING (B)(6) 2022 DUE TO THE NATIONWIDE SHORTAGE OF SALINE SOLUTION TO CLEAN PORT (BILIARY) DRAINAGE FROM WOUND SITE. THE PATIENT DEVELOPED LIFE-THREATENING MRSA AT THAT SITE SHORTLY IN (B)(6) 2022. ACCORDING TO RECORDS, WOUND CULTURE WAS COLLECTED ON (B)(6) 2022 WITH A POSITIVE RESULT FOR MRSA ON (B)(6) 2022. THE PATIENT WAS HOSPITALIZED AND PUT ON STRONG ANTIBIOTIC (VANCOMYCIN) TREATMENT THEREAFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223137 0.9% SODIUM CHLORIDE IRRIGATION USP SALINE, VASCULAR ACCESS FLUSH NGT NURSE ASSIST, LLC. 21071702

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown