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

Model Number	6281
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Codes	Bacterial Infection (1735); Respiratory Tract Infection (2420)
Date of Event	11/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 08-nov-23, nurse assist received a complaint via e-mail from (b)(6) of the following event description from e-mail: i used the nurse assist sodium chloride solution for irrigation, and i became ill following this use.Please let me know which specific contaminant (ie bacteria) was found in the solution.My doctor directed me to get this information from nurse assist asap so he can treat me with the correct antibiotic.I am immune-compromised and became ill following my use of this product.I know i used bottles from lot #22124474 and lot #23065735.However, i have been using this product regularly for a while, so i have also used bottles from other lots (i no longer have those bottles, as they were disposed of prior to the announcement of the recall, so i cannot provide additional lot numbers).I do have records of the purchases in my amazon account.

• 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: 18401981
• Report Number: 3002695476-2023-00018
• Device Sequence Number: 2674944
• Product Code: FRO
• UDI-Device Identifier: 00850421008846
• UDI-Public: (01)00850421008846
• Combination Product (Y/N): N
• 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): 12/19/2023

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: 12/08/2024
• Device Model Number: 6281
• Device Catalogue Number: N/A
• Device Lot Number: 22124474
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown