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

Model Number	6270
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	09/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 08-feb-2024, nurse assist received a complaint from mark boltax via phonecall.Description of phonecall: mark boltax started using 6270 bottles in january 2023 once a month to irrigate his foley catheter.After initial use, boltax would dispose the bottle.Between the months september 2023 and december 2023, boltax contracted a uti.Doctors prescribed him multiple antibiotics due to the pathogen changing.

• 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: 18741786
• Report Number: 3002695476-2024-00011
• Device Sequence Number: 7243502
• Product Code: FRO
• UDI-Device Identifier: 00850421008822
• UDI-Public: 850421008822
• 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): 02/16/2024

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: 08/10/2025
• Device Model Number: 6270
• Device Lot Number: 23086230
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2023
• 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