MAUDE Adverse Event Report: UNKNOWN SALINE FLUSH SOLUTION; SALINE, VASCULAR ACCESS FLUSH

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Information (3190)

Event Type  No Answer Provided  

Event Description

Saline flush solutions that we are contracted to purchase do not scan on administration.It appears the manufacturer embeds the lot number and expiration date within the barcode, which changes with different batches, the number that should be associated with the barcode is the ndc number (this is our facilities impression of what is going on).(b)(4).

• Brand Name: SALINE FLUSH SOLUTION
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8659433
• MDR Text Key: 147027653
• Report Number: MW5087072
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1