MAUDE Adverse Event Report: THE RITEDOSE CORPORATION SODIUM CHLORIDE INHALATION SOLUTION 7% UNIT-DOSE VIAL; NEBULIZER (DIRECT PATIENT INTERFACE)

Patient Problem Insufficient Information (4580)

Event Type  Other  

Event Description

Sodium chloride inhalation solution 3% and 7% from ritedose pharmaceuticals do not have the strength indicated on the neb itself.As a hospital that uses this medication, we have to manually label the product with a sticker when it is removed from the box to dispense to patients or to adc.However, if the sticker falls off or is otherwise rendered unreadable/unscannable, there is no way for the clinician to know what strength the product is.Https://ritedose.Com/wp-content/uploads/2023/03/rdp sodiumchloride-3-7pct cartons.Pdf (https://ritedose com/wp-content/uploads/2023/03/rdp sodiumchloride-3-7pct cartons.Pdf).Ismp is a federally certified patient safety organization and an fda medwatch partner.Ismp, 5200 butler pike, plymouth meeting, pa 19462; phone: 215-947-7797; email: merp@ismp.Org.Submission id: (b)(4).Reference report: mw5144981.

• Brand Name: SODIUM CHLORIDE INHALATION SOLUTION 7% UNIT-DOSE VIAL
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): THE RITEDOSE CORPORATION
• MDR Report Key: 17631139
• MDR Text Key: 322192630
• Report Number: MW5144980
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1