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

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Protective Measures Problem (3015)

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

Event Description

Potential for error involving sodium chloride 3% inhalation solution (ndc: 0487-9003-60) and sodium chloride 7% inhalation solution.(ndc: 0487- 9007-60) manufactured by nephron pharmaceuticals.Products arrive in go-count boxes differentiated only by ndc, percentage strength, and colored pixelated stripe on box (brown for 3% and gray for 7%).Unit dose vial itself is clear plastic with product description embossed into plastic with only differentiating factors being percentage strength.Wording is very difficult to read.Unit dose products are the same in size, appearance, and volume.No overwrap or barcode is available for scanning.Typically, institution receives sodium chloride 3% inhalation solution from a hospital system central packaging facility in which vials are individually wrapped and barcoded.However, at time when these became unavailable through central packager, bulk box was obtained creating potential for error in dispensing.(b)(6).Submission id: (b)(4).

• Brand Name: SODIUM CHLORIDE INHALATION SOLUTION 7%
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): NEPHRON SC, INC.
• MDR Report Key: 12934089
• MDR Text Key: 281940250
• Report Number: MW5105803
• Device Sequence Number: 2
• 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: 09/20/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1