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

Model Number	37-6260
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	02/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An email was sent to prodct removal info email addres by (b)(6) on december 31, 2023.The email was forwarded to the complaints department on 5/23/24, 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 5/23/24, 6/10/2024, and 6/17/2024 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.
Event or Problem Description
Comments included in email received from complaints: i purchased cases of your sterile water to flush my catheters that were placed in my urethra into my bladder from (b)(6) 2023 to approximately (b)(6) 2023.I purchased the following from (b)(6) who alerted me of your safety recall: 2 each of sterile irrigation water 250ml 24 bottles on april 22, 2023 on order # (b)(6) for a total of $(b)(6) and may 14, 2023 on order # (b)(6) for a total of (b)(6).We have used all of these 48 bottles.1 each of mckesson sterile water, usp, single patient use, not for injection, 250 ml, 24 count at (b)(6) on may 30, 2023 on order # (b)(6) for a total of $(b)(6).We have used 12 of these 24 bottles and have 12 remaining.I have had bladder and yeast infections since using these products and i also have prostate cancer that was discovered after my biopsy on (b)(6) 2023 that was the reason for the first catheter.You have stated to fda that there have been no reported adverse effects.I am not certain of that fact.I am immunocompromised due to diabetes and cancer.

• 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: 19570719
• Report Number: 3002695476-2024-00031
• Device Sequence Number: 6954857
• Product Code: FRO
• UDI-Device Identifier: 00612479199569
• UDI-Public: 612479199569
• 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): 06/17/2024

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: 37-6260
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 06/19/2024
• 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