MAUDE Adverse Event Report: NURSE ASSIST, LLC NURSE ASSIST, LLC; STERILE WATER FOR IRRIGATION USP IN SCREW BOTTLE TOP

Model Number	6260
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An email was sent to product remove info email by (b)(6) on 11/08/23.The email was forwarded to the complaints department on 6/13//24, 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 6/13/24 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.
Event or Problem Description
Comments included in email received from complaints: we have continuously use this product to flush my husband's catheter 4 times a week and have been for a very long time.Someone needs to reach out to me asap to fully explain the warning to stop using immediately.He has been having a lot of issues with white floating substances clogging his catheter causing multiple trips to the doctor.My home number is (b)(6) and my name is (b)(6).We have two orders here to return but i'm more concerned about the full reason of the recall and what is safe to use in its place starting tomorrow.When attempting to call, there was no answer and the mailbox is full so i could not leave a message and no one is answering.I am est so please reach back out asap.

• Brand Name: NURSE ASSIST, LLC
• Common Device Name: STERILE WATER 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: 19614888
• Report Number: 3002695476-2024-00039
• Device Sequence Number: 14980659
• Product Code: FRO
• UDI-Device Identifier: 00850421008778
• UDI-Public: 850421008778
• 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): 06/20/2024

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 Model Number: 6260
• 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: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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