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

Model Number	6281
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Codes	Drug Resistant Bacterial Infection (4553); Unspecified Tissue Injury (4559)
Date of Event	05/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medwatch report mw5149040.
Event or Problem Description
On 13-dec-23, nurse assist received a medwatch report via e-mail of the following event description from medwatch report: i used the nurse assist llc sterile saline product to irrigate a seroma in my abdomen from (b)(6) of 2023.I have since had 3 débridement surgeries to clear damaged tissue from my wound.I had two as an out patient and the most recent inpatient.They only did a culture on the most recent and it grew out mrsa (methicillin-resistant staphylococcus aureus).I have been progressively sicker since may.Significant physical deterioration since (b)(6).

• 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: 18475009
• Report Number: 3002695476-2023-00042
• Device Sequence Number: 6407525
• Product Code: FRO
• UDI-Device Identifier: 00850421008846
• UDI-Public: (01)00850421008846
• 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
• 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: 03/03/2025
• Device Model Number: 6281
• Device Lot Number: 23034968
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2023
• 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: Required Intervention; Hospitalization; Disability; Life Threatening
• Patient Sex: Unknown