MAUDE Adverse Event Report: THE RITEDOSE CORPORATION SODIUM CHLORIDE INHALATION SOLUTION, USP, 0.9% 3ML; NEBULIZER (DIRECT PATIENT INTERFACE)

Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Manufacturing, Packaging or Shipping Problem (2975); Application Program Problem: Medication Error (3198)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Viral Infection (2248)
Date of Event	12/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This spontaneous report from the united states was reported by a 66-year-old female patient who experienced influenza, no muscle in legs, had to use some of the half doses of sodium chloride inhalation solution 0.9% and complained that 85 vials out of 100 vials in the package were only filled halfway and vials have water bubbles.Co-suspect product included brom-pse-dm (brompheniramine maleate, pseudoephedrine hcl, dextromethorphan hydrobromide).On (b)(6)2024, the patient picked up her prescription.On an unspecified date in (b)(6) 2024, the patient initiated the sodium chloride inhalation solution 0.9%, as prescribed, three times a day and up to four additional times as needed for her copd.The patient had been taking sodium chloride inhalation solution 0.9% every 8 to 12 hours as needed for copd/ emphysema for several years.On (b)(6)2024, the patient discovered that 85 out of the 100 vials in the package were only filled halfway, raising concerns about volume inconsistencies.The patient noticed the issue after realizing that the vials were running out quickly and that water bubbles were inside.It was reported that she had been feeling very ill, requiring a visit to her doctor while being on oxygen and experiencing breathing difficulties.At the time of reporting, she had only two full vials remaining and had to use some of the partially filled vials, resulting in reduced doses.The patient stated that she did not return the product as she had already finished it., she stopped using sodium chloride inhalation solution 0.9% on an unspecified date in (b)(6) 2024.On (b)(6)2024, she was hospitalized for influenza and was informed by her doctors that her flu was caused by excessive steroid use (prednisone) and elevated carbon dioxide levels in her body.She reported feeling as though she had no muscle strength in her legs.On (b)(6)2025, she was transferred to a rehabilitation facility and was discharged home on (b)(6)2025.During her hospitalization, the patient was weaned off steroids, and sodium chloride inhalation solution 0.9% was not reinitiated.No additional information was available at the time of reporting.Action taken with sodium chloride inhalation solution 0.9% was drug withdrawn.The outcome of events influenza and no muscle in my legs was unknown.The outcome of the events had to use some of the half doses, 85 vials out of 100 vials in the package are only filled halfway and vials have water bubbles was not applicable.

• Brand Name: SODIUM CHLORIDE INHALATION SOLUTION, USP, 0.9% 3ML
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): THE RITEDOSE CORPORATION; 1 technology circle; columbia SC 29203
• Manufacturer (Section G): THE RITEDOSE CORPORATION; 1 technology circle; colombia SC 29203
• Manufacturer Contact: arianne lindsey ; 1 technology circle; colombia,, SC 29203 ; 8039354114
• MDR Report Key: 21686181
• Report Number: 3001237796-2024-00138
• Device Sequence Number: 15773409
• Product Code: CAF
• UDI-Device Identifier: 00376204300032
• UDI-Public: 00376204300032
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALBUTEROL [SALBUTAMOL].; BREZTRI AEROSPHERE.; FLUTICASONE.; OXYGEN.; PREDNISONE.; SYMBICORT TURBUHALER.; TRELEGY.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female