MAUDE Adverse Event Report: PARI RESPIRATORY EQUIPMENT, INC. 7% SODIUM CHLORIDE INHALATION SOLUTION; NEBULIZER (DIRECT PATIENT INTERFACE)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Other  

Event Description

Sodium chloride 7% neb manufactured by pari respiratory (https:·//www.Pari com/us/products/inhalation-solutions-us/generic-nad-us/ (https·//www pari.Com/us/products/inhalation-solutions-us/generic-nad-us/) noc: 83490-0307-60 - not packaged as unit dose and individual barcode; must make custom barcodes for refilling to pyxis and for bcma; very difficult to confirm strength (see pic); has led to filling errors and general confusion with pharmacy staff confusing the different concentrations since not clearly identifiable.(b)(6).Submission id: (b)(4).

• Brand Name: 7% SODIUM CHLORIDE INHALATION SOLUTION
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 18573641
• MDR Text Key: 333777746
• Report Number: MW5150662
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1