MAUDE Adverse Event Report: NURSE ASSIST, LLC NURSE ASSIST, LLC; 0.9% NORMAL SALINE FOR IRRIGATION USP IN SCREW BOTTLE TOP

Model Number	6281
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Codes	Unspecified Infection (1930); Septic Shock (2068)
Date of Event	02/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 13-dec-23, nurse assist received a medwatch report via e-mail of the following event description from medwatch report: 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 (b)(6) 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 wound/surgical site at drs office.
Additional Manufacturer Narrative
Medwatch report mw5149044.

• Brand Name: NURSE ASSIST, LLC
• Common Device Name: 0.9% NORMAL SALINE FOR IRRIGATION USP IN SCREW BOTTLE TOP
• Manufacturer (Section D): NURSE ASSIST, LLC; 4409 haltom rd.; haltom city TX 76117
• Manufacturer (Section G): NURSE ASSIST, LLC; 4409 haltom rd.; haltom city TX 76117
• Manufacturer Contact: anthony bui ; 4409 haltom rd.; haltom city, TX 76117 ; 8006496800
• MDR Report Key: 18475026
• Report Number: 3002695476-2023-00045
• Device Sequence Number: 6944143
• Product Code: FRO
• UDI-Device Identifier: 00850421008846
• UDI-Public: (01)00850421008846
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K083042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/29/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 6281
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Unknown