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

Lot Number 22083817

Patient Problems Septic Shock (2068); Fungal Infection (2419)

Event Type  Death  

Event Description

Cder received the medwatch report.The reporter states the impacted individual had an ulcer wound that got infected with candida auris.They washed the wound daily with water.There were white spores (fungal growth) around the wounds.The hospital determined that candida auris got into the blood stream of the impacted individual and the individual went into septic shock and died.The reporter stated that they have the medical records for the deceased individual.Infection leading to death.

• Brand Name: 0.9% SODIUM CHLORIDE IRRIGATION USP
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): NURSE ASSIST, LLC.
• MDR Report Key: 18191678
• MDR Text Key: 328911916
• Report Number: MW5148357
• 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: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Lot Number: 22083817
• Patient Sequence Number: 1
• Patient Outcome(s): Death