MAUDE Adverse Event Report: NEPHRON SODIUM CHLORIDE NEBULIZER

Lot Number 6L150

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Some single dose unit packaging of certain products does not come with a barcode.Or it comes with a barcode for that can be lost easily if the package was opened (e.G.Sodium chloride nebulizers).Other single dose unit packing of products come with a barcode, however, our system (meditech) is unable to read the barcode.The problem occurs when we try to administer these products to patients on the floor.Nurses are unable to scan the product prior to administering the product to the patients.Having manufacturers place a readable barcode on single dose unit packaging will greatly aid in reducing medication errors on the floors.

• Brand Name: SODIUM CHLORIDE NEBULIZER
• Type of Device: SODIUM CHLORIDE NEBULIZER
• Manufacturer (Section D): NEPHRON
• MDR Report Key: 6471325
• MDR Text Key: 72278812
• Report Number: MW5068960
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 8349030760
• UDI-Public: 83490-307-60
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 6L150
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1