MAUDE Adverse Event Report: NURSE ASSIST, LLC. NURSE ASSIST STERILE IRRIGATION; SALINE, VASCULAR ACCESS FLUSH

Patient Problems Unspecified Infection (1930); Sepsis (2067)

Event Date 11/07/2023

Event Type  Injury  

Event Description

Surgical site infection/sepsis due to possible contaminated sterile water exposure.Nurse assist sterile irrigation water possibly used in cardiac surgery which resulted in surgical site and blood stream infection with serratia marcescens.3 sterile site cultures collected on (b)(6) 2023 during incision and drainage, sternum with debridement all grew serratia marcescens.Initial surgery 11/7.Blood cultures collected on (b)(6) and (b)(6) also grew serratia.

• Brand Name: NURSE ASSIST STERILE IRRIGATION
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): NURSE ASSIST, LLC.
• MDR Report Key: 18239833
• MDR Text Key: 329477185
• Report Number: MW5148598
• 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: Unknown
• Type of Report: Initial
• Report Date: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• 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): Hospitalization; Life Threatening
• Patient Age: 45 YR
• Patient Sex: Male