MAUDE Adverse Event Report: NURSE ASSIST, LLC. 0.9% SODIUM CHLORIDE; SALINE, VASCULAR ACCESS FLUSH

Patient Problem Bacterial Infection (1735)

Event Date 01/05/2024

Event Type  Injury  

Event Description

Culture of my sphenoid sinus found a rare bacteria.I have debilitating symptoms and awaiting treatment options.Around the time of my culture i was notified of recall of 0.9% sodium chloride by nurse assist which i use for sinus rinses because i am immunocompromised and doctor wanted sterilization for sodium chloride rinse.

• Brand Name: 0.9% SODIUM CHLORIDE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): NURSE ASSIST, LLC.
• MDR Report Key: 18563278
• MDR Text Key: 333547577
• Report Number: MW5150624
• 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: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White