MAUDE Adverse Event Report: NURSE ASSIST, LLC 0.9% SODIUM CHLORIDE STERICARE SOLUTIONS; SALINE, VASCULAR ACCESS FLUSH

Lot Number 6281

Patient Problems Unspecified Infection (1930); Septic Shock (2068)

Event Date 02/23/2023

Event Type  Injury  

Event Description

My son, who is immunocompromised, was seen by his podiatrist for an ingrown toe nail> a portion of the nail was removed and it was cleaned with stericare 0.9% sodium chloride irrigation batch number 6281.This has been recalled due to not being sterile.This was used on an open would/surgical site on my son.He was put on an antibiotic to try and prevent infection.A week later the toe was getting much worse, the dr again cleaned the wound out and used this same solution to clean it and another antibiotic.In the weeks that followed my son was seen by his pediatrician and as well as an urgent care.He was on several different antibiotics but on march 15th he was doing very bad.We took him to (b)(6) hospital where he was admitted to icu.He had several bacteria growing in his toe, he was in septic shock and the infection had spread to his bone.He spent almost 2 weeks in the hospital, being admitted to the icu 2 times while there.He needed several antibiotics, including iv antibiotics.He needed multiple tests, xrays, and mris.As well as weeks of antibiotics after leaving the hospital.Reason for use: to clean a would/surgical site at drs office.

• Brand Name: 0.9% SODIUM CHLORIDE STERICARE SOLUTIONS
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): NURSE ASSIST, LLC
• MDR Report Key: 18300926
• MDR Text Key: 330167235
• Report Number: MW5149044
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 6281
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: HIZENTRA; PEROXICAM; ZYRTEC
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 13 YR
• Patient Sex: Male
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White