MAUDE Adverse Event Report: NURSE ASSIST, LLC 6280 STERILE USP NORMAL SALINE 0.9% SODIUM CHLORIDE; SALINE, VASCULAR ACCESS FLUSH

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

Event Date 08/27/2023

Event Type  Other  

Event Description

Product was sold as sterile saline and it wasn't.I put my trust in the product and it could have lead to infection.Used 1 week.

• Brand Name: 6280 STERILE USP NORMAL SALINE 0.9% SODIUM CHLORIDE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): NURSE ASSIST, LLC
• MDR Report Key: 18399613
• MDR Text Key: 331542160
• Report Number: MW5149583
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/21/2023

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?: No
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/26/2023
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Sex: Female
• Patient Weight: 48 KG
• Patient Ethnicity: Hispanic
• Patient Race: White