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

Model Number	37-6240
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	12/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 15-dec-23, nurse assist received a medwatch report via e-mail of the following event description from medwatch report: my husband has a sci (spinal cord injury).We have been using mckesson saline mixed with gentamicin as a bladder rinse to prevent urinary tract infections.He had 9 uti's in one year, unexplained.Now we find out that the saline we were using is part of a recall.Could that have attributed to all the uti's that he had? i am giving the date of his last urine culture.He was treated with cipro.Dates of use: (b) (6) 2016 - (b)(6) 2023.Bladder rinse per urologist to prevent uti.
Additional Manufacturer Narrative
Medwatch report mw5149118.

• 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: 18475008
• Report Number: 3002695476-2023-00046
• Device Sequence Number: 6407524
• Product Code: FRO
• UDI-Device Identifier: 00612479199545
• UDI-Public: 612479199545
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Type of Report: Initial
• Report Date (Section B): 12/29/2023

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: 03/08/2024
• Device Model Number: 37-6240
• Device Lot Number: 22032904
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2022
• 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: Other
• Patient Sex: Unknown