BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERICARE SOLUTIONS

    MDR report key: 25074637 · Received May 4, 2026

    Report

    Report Number
    3002695476-2026-00001
    Event Type
    Injury
    Date Received
    May 4, 2026
    Date of Event
    February 23, 2024
    Report Date
    May 4, 2026
    Manufacturer
    NURSE ASSIST, LLC
    Product Code
    FRO
    UDI-DI
    00850421008815
    PMA / PMN Number
    K083042
    Removal / Correction Number
    1650927-3OCT2023-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION WAS RECEIVED TO CONFIRM THIS COMPLAINT OR CONDUCT ADDITIONAL INVESTIGATION. MDR SUBMISSION IS BASED ON EVENT REPORTED TO NURSE ASSIST. IF MORE INFORMATION IS RECEIVED, ADDITIONAL INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 0

    ON (B)(6) 2026, NURSE ASSIST RECEIVED A COMPLAINT FROM CARDINAL HEALTH. THE EVENT WAS DESCRIBED AS: "THE COMPLAINT ALLEGES THAT IN (B)(6) 2019, THE PLAINTIFF WAS IMPLANTED WITH A MECHANICAL HEART THAT CONNECTS TO A BATTERY PACK VIA A MEDICAL WIRE THAT REQUIRES ONGOING USE OF WOUND CARE PRODUCTS, INCLUDING STERILE SALINE, TO PREVENT INFECTION. PLAINTIFF ALLEGEDLY PURCHASED WOUND CARE KITS, WHICH INCLUDED THE STERILE SALINE, FROM ORTHODYNAMICS COMPANY, INC. AND THE KITS WERE ALLEGEDLY MANUFACTURED AND/OR SUPPLIED BY CARDINAL HEALTH AND/OR NURSE ASSIST. IN (B)(6) 2023, THE FDA INITIATED A RECALL OF THE STERILE SALINE SOLUTION BECAUSE A DEFECT COULD COMPROMISE THE STERILITY AND ALLOW BACTERIA TO ENTER WITHIN THE KITS/SALINE BOTTLES. ACCORDING TO THE COMPLAINT, THE STERILE SALINE ALLEGEDLY CONTINUED TO BE SOLD AND PLAINTIFF CONTINUED USING IT. ON (B)(6) 2024, PLAINTIFF ALLEGEDLY NOTICED REDNESS AND PAIN AT HER WIRE INSERTION SITE AND DEVELOPED AN INFECTION PURPORTEDLY CAUSED BY THE CONTAMINATED STERILE SALINE. THE INFECTION ALLEGEDLY REMAINS IN HER BLOOD TODAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629495 STERICARE SOLUTIONS USP NORMAL SALINE FRO NURSE ASSIST, LLC 6240 00850421008815

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other