MAUDE Adverse Event Report: MYLAN PHARMACEUTICALS INC. SODIUM CHLORIDE INHALATION SOLUTION; NEBULIZER (DIRECT PATIENT INTERFACE)

Patient Problem Insufficient Information (4580)

Event Type  Other  

Event Description

Potential source for errors: mylan brand sodium chloride inhalation solutions in the 3% and 10% strengths are indistinguishable.The 0.9% sodium chloride solution comes in clear pink nebules and is easy to identify.The 3% and 10% sodium chloride solution nebules are both clear/white and the only way to distinguish these is to find the printed "3%" and "10%" on the bodies of the nebules.Please see pictures below.We often use the 0.9%, 3%, and 10% strengths to compound a 4% and 5% strengths for sputum induction procedures.(b)(6).Submission id: (b)(4).

• Brand Name: SODIUM CHLORIDE INHALATION SOLUTION
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): MYLAN PHARMACEUTICALS INC.
• MDR Report Key: 17869714
• MDR Text Key: 324980155
• Report Number: MW5146507
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1