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

Lot Number 21071702

Patient Problem Bacterial Infection (1735)

Event Type  Other  

Event Description

The reporter states that they ordered and used 0.9% sodium chloride irrigation usp (stericare solutions) made by nurse assist, inc on a patient beginning (b)(6) 2022 due to the nationwide shortage of saline solution to clean port (biliary) drainage from wound site.The patient developed life-threatening mrsa at that site shortly in (b)(6) 2022.According to records, wound culture was collected on (b)(6) 2022 with a positive result for mrsa on (b)(6) 2022.The patient was hospitalized and put on strong antibiotic (vancomycin) treatment thereafter.

• Brand Name: 0.9% SODIUM CHLORIDE IRRIGATION USP
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): NURSE ASSIST, LLC.
• MDR Report Key: 18191688
• MDR Text Key: 328959477
• Report Number: MW5148358
• 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
• Type of Report: Initial
• Report Date: 11/16/2023

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
• Device Expiration Date: 08/04/2023
• Device Lot Number: 21071702
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2023
• Patient Sequence Number: 1