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	Urinary Tract Infection (2120)
Date of Event	01/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Comments included in email received from complaints: i purchased a 48 count, 100ml case of normal saline & just found out it has a recall on it.What do i need to do to rectify this? i have used 18 bottles for bladder irrigation and am currently on antibiotics because of infection that i now believe could be due to the use of this product.I obviously have stopped using immediately.
Additional Manufacturer Narrative
An email was sent to product remove info email by (b)(6) 2024.The email was forwarded to the complaints department on (b)(6) 2024, which initiated nurse assist's investigation of the reported incident and determination that the noted incident was reportable.A follow-up email was sent to (b)(6) by the complaints department on 5/29/24 and 6/19/2024 requesting additional information to aid with reporting and with the investigation.The product removal info email address was intended to be used solely for facilitating return and replacement of product and was not being reviewed for complaint information, which resulted in the delay of reporting this incident.The product removal info email inbox is being expeditiously reviewed to identify any other incident related information that would be considered as a complaint.

• 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: 19615058
• Report Number: 3002695476-2024-00034
• Device Sequence Number: 6018104
• Product Code: FRO
• UDI-Device Identifier: 00850421008815
• UDI-Public: 850421008815
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/19/2024

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: 06/19/2025
• Device Model Number: 6240
• Device Lot Number: 23065855
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown