BEUDAMED
    FDA Adverse Event Death Summary report: N

    10ML 0.9% SODIUM CHLORIDE FLUSH

    MDR report key: 18300610 · Received December 8, 2023

    Report

    Report Number
    MW5149038
    Event Type
    Death
    Date Received
    December 8, 2023
    Date of Event
    December 2, 2022
    Report Date
    November 10, 2023
    Manufacturer
    NURSE ASSIST, LLC.
    Product Code
    NGT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY HUSBAND WAS DIAGNOSED WITH LARYNGEAL CANCER ON (B)(6) 2022 AND HAD A TRACH PLACED IMMEDIATELY IN THE ER(EMERGENCY ROOM) AT (B)(6). HE WAS TREATED FROM (B)(6) 2022 THROUGH (B)(6) 2022. HE WAS HOSPITALIZED 4 DIFFERENT TIMES AT MAYO FROM (B)(6) 2022 THROUGH (B)(6) 2023 FOR REPEATED INFECTIONS. DURING THIS TIME, I WAS HAVING TO CLEAN (B)(6)'S TRACH BY COMPLETELY REMOVING IT AND FLUSHING IT WITH SALINE WATER BEFORE REENTERING IT INTO HIS STOMA, RINSING THE INNER CANNULA, AND CLEANING AROUND HIS FEEDING TUBE WITH 0.9% SALINE SOLUTION AND SALINE WATER GIVEN TO ME FROM MAYO IN (B)(6). ALSO, I HAD TO ADMINISTER SALINE FLUSHES FOR IV INFUSIONS 3X A DAY FOR 9 DAYS EACH OF THOSE TIMES AT HOME 2 SEPARATE TIMES AFTER HOSPITALIZATION DUE TO BACTERIAL INFECTIONS. FIRST ADMINISTERED SALINE SYRINGE FLUSHES 10ML BEFORE AND AFTER IN HIS MIDLINE BEFORE ADMINISTERING CEFAZOLIN. THE SECOND TIME WAS 10ML BEFORE AND AFTER IN HIS MIDLINE BEFORE ADMINISTERING CEFEPIME. (B)(6) PASSED AWAY ON (B)(6) 2023, 3 DAYS AFTER HIS LAST HOSPITALIZATION. IT IS MY CONCERN THAT (B)(6) REPEATED BACTERIAL INFECTIONS MAY HAVE BEEN LINKED TO THE EXCESSIVE USE OF 0.9% CONTAMINATED SALINE SOLUTION AND SALINE WATER DURING THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1772433 10ML 0.9% SODIUM CHLORIDE FLUSH SALINE, VASCULAR ACCESS FLUSH NGT NURSE ASSIST, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Other| H| D| S PROBIOTIC