MAUDE Adverse Event Report: PHARMACARIBE LLC NEBUSAL SODIUM CHLORIDE SOLUTION 3% 60 X 4 ML UNIT DOSE VIAL; NEBULIZER (DIRECT PATIENT INTERFACE)

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

Event Type  Other  

Event Description

(reported during monthly pso client meeting) we are seeing an increase in near miss reports related to confusion between 3% and 7% sodium chloride nebulizer solutions.Individual wrapped packaging options have been difficult to obtain; therefore, the hospital must purchase bulk packaging.When available, individual package labels were easy to read and included a barcode which was used by respiratory staff during medication administration.The bulk supply includes no barcode and the product description is extremely difficult to read.To maintain bcma compliance, pharmacy staff need to manually label each vial (e.G., respule) with a barcoded label.The label is flagged; however, there is risk that the label may fall off or get stuck to a different vial as the plastic vial does not allow for the best label adherence.Individually labeling each inhalation vial is very labor intensive for our large integrated health network (8 total hospitals; main hospital is 725 beds).Current product is manufactured by "pharmacaribe": sodium chloride 3% solution - ndc 50190-142-63 ¿ sodium chloride 7% solution - ndc 50190-141-23.It's hard to capture, but all of the product information is captured on the long tab portion of the nebulizer package.The other side includes the expiration date.Each nebulizer must be individually separated and have an individual barcode manually applied prior to dispensing or loading into an automated dispensing cabinet.Ismp is a federally certified patient safety organization and an fda medwatch partner.(b)(6).Submission id: (b)(4).Reference report: mw5144983.

• Brand Name: NEBUSAL SODIUM CHLORIDE SOLUTION 3% 60 X 4 ML UNIT DOSE VIAL
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PHARMACARIBE LLC
• MDR Report Key: 17632638
• MDR Text Key: 322245588
• Report Number: MW5144982
• 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