MAUDE Adverse Event Report: NURSE ASSIST, LLC STERICARE 0.9% SODIUM CHLORIDE IRRIGATION USP, 250ML; SALINE, VASCULAR ACCESS FLUSH

Model Number 6270

Patient Problem Unspecified Infection (1930)

Event Date 10/21/2023

Event Type  Death  

Event Description

Used the recalled product to clean an open wound on right foot, and developed an infection which required an antibiotic to resolve on (b)(6) 2023.Open wound to right foot.

• Brand Name: STERICARE 0.9% SODIUM CHLORIDE IRRIGATION USP, 250ML
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): NURSE ASSIST, LLC
• MDR Report Key: 18358050
• MDR Text Key: 330975295
• Report Number: MW5149357
• 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: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 6270
• Device Lot Number: 23076070
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2023
• Patient Sequence Number: 1
• Treatment: 81MG ASPIRIN ; CALCIUM; JANUVISA; LANTUS INSULIN ; METFORMIN ; MULTIVITAMIN ; NOVALOG INSULIN ; TRULICITY ; VITAMIN E, VITAMIN D
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Race: White, American Indian Or Alaskan Native