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

Model Number	37-6270, 1020
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Codes	Bacterial Infection (1735); Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint (b)(4) from medwatch reports mw5153041 and mw5153042.
Event or Problem Description
From medwatch report (mw5153041): nurse assist manufactured saline for bladder irrigation potentially caused an increase in urinary tract infections in immunocompromised patient.Culture results showed the following results: serratia marcescens and citrobacter koseri - (b)(6) 2024, citrobacter koseri - (b)(6) 2024, citrobacter koseri - (b)(6) 2024, serratia marcescens - (b)(6) 2023, serratia marcescens - (b)(6) 2023 - also on (b)(6) 2023.Bladder irrigation, twice daily.Reference report: mw5153042.From medwatch report (mw5153042): nurse assist manufactured saline for bladder irrigation potentially caused an increase in urinary tract infections in immunocompromised patient.Culture results showed the following results: serratia marcescens and citrobacter koseri - (b)(6) 2024, citrobacter koseri - (b)(6) 2024, citrobacter koseri - (b)(6) 2024, serratia marcescens - (b)(6) 2023, serratia marcescens - (b)(6) 2023 - also on (b)(6) 2023.Bladder irrigation, twice daily.Reference report: mw5153041.

• Brand Name: NURSE ASSIST
• 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: rebeca masdon-mercado ; 4409 haltom rd; haltom city, TX 76117 ; 8006496800
• MDR Report Key: 19237438
• Report Number: 3002695476-2024-00015
• Device Sequence Number: 8107085
• Product Code: FRO
• UDI-Device Identifier: 00612479199576
• UDI-Public: 612479199576
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/05/2024

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
• Device Expiration Date: 08/11/2024
• Device Model Number: 37-6270, 1020
• Device Lot Number: 22083817, 22104138
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Unknown