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

Model Number	37-6270
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Codes	Septic Shock (2068); Fungal Infection (2419)
Date of Event	09/22/2023
Type of Reportable Event	Death
Event or Problem Description
On 12-dec-23, nurse assist received a complaint via e-mail from fda medwatch of the following event.Description from medwatch report: there was so many test done on my mother, i have all of her medical records.Her ulcer wound got infected with candida auris, we would wash the wound daily with water.She had white spores fungi growth around the wounds and she had a "catheter" as well.The hospital said the candida auris got into her blood, she went into septic shock and died.I purchased the water for her.If i would have known there was any likely hood of known "ing", it was not sterile.I would never brought for her because i knew we cant use tap water.
Additional Manufacturer Narrative
Medwatch report mw5149035.

• Brand Name: NURSE ASSIST, LLC
• Common Device Name: 0.9% NORMAL SALINE FOR IRRIGATION USP, IN SCREW TOP BOTTLE
• 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: 18402522
• Report Number: 3002695476-2023-00031
• Device Sequence Number: 11754167
• Product Code: FRO
• UDI-Device Identifier: 00612479199576
• UDI-Public: 612479199576
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2023

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 Expiration Date: 08/11/2024
• Device Model Number: 37-6270
• Device Lot Number: 22083817
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2022
• 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: Death
• Patient Sex: Unknown