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

Model Number	6240
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, nurse assist received a call from (b)(6) description of call: (b)(6) was taking care of a family member who had a deep wound that required a drainage since middle of june.Around december 30th the wound started to smell.A visiting nurse came on (b)(6) 2024 to clean the deep wound.During the cleaning, large amount of pus was released.On (b)(6) 2024, nurse assist called back (b)(6) to obtain more information about the incident.Description of call: (b)(6) stated that they reused the product for multiple cleaning sessions and stored the product in room temperature.The product was received in a plastic bag and mr.Kurpunski did not find any signs leakage inside of the bag after visually inspecting it.

• 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: 18601519
• Report Number: 3002695476-2024-00005
• Device Sequence Number: 9016694
• Product Code: FRO
• UDI-Device Identifier: 00850421008815
• UDI-Public: 850421008815
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 01/22/2024

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: 03/21/2025
• Device Model Number: 6240
• Device Lot Number: 23035093
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2023
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown