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

Patient Problems Bacterial Infection (1735); Fever (1858); Pain (1994); Sepsis (2067); Tachycardia (2095); Malaise (2359)

Event Date 01/31/2023

Event Type  Injury  

Event Description

Used nurse assist 0.9% sodium chloride irrigation usp and sterile water for irrigation of bladder via catheter.Two days later was very sick with high fever, tachycardia and general malaise.Walk in clinic tests showed high levels of white blood cells and referred to er for immediate evaluation.Er diagnosed me with acute bacterial prostatitis and sepsis.I was admitted to the hospital that day for iv antibiotics, frequent blood work and observation.I responded well the to treatment after 2 days and was released to finish antibiotics at home.Since then i have had many complications from this infection.My urologists tell me healing from this type of infection is slow and the daily prostate pain i have now may be chronic and here to stay.There are lasting effects.This product has recently been recalled for lack of sterility confidence.Ref report: mw5149037.

• Brand Name: 0.9% SODIUM CHLORIDE IRRIGATION USP
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): NURSE ASSIST, LLC.
• MDR Report Key: 18300507
• MDR Text Key: 330162202
• Report Number: MW5149036
• 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: 11/17/2023

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?: No
• Device Expiration Date: 11/30/2023
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Life Threatening; Hospitalization
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 131 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White