MAUDE Adverse Event Report: NURSE ASSIST, LLC STERICARE SOLUTIONS; USP NORMAL SALINE

Model Number	6240
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No additional information was received to confirm this complaint or conduct additional investigation.Mdr submission is based on event reported to nurse assist.If more information is received, additional investigation will be completed.
Event or Problem Description
On (b)(6) 2026, nurse assist received a complaint from cardinal health.The event was described as: "the complaint alleges that in (b)(6) 2019, the plaintiff was implanted with a mechanical heart that connects to a battery pack via a medical wire that requires ongoing use of wound care products, including sterile saline, to prevent infection.Plaintiff allegedly purchased wound care kits, which included the sterile saline, from orthodynamics company, inc.And the kits were allegedly manufactured and/or supplied by cardinal health and/or nurse assist.In (b)(6) 2023, the fda initiated a recall of the sterile saline solution because a defect could compromise the sterility and allow bacteria to enter within the kits/saline bottles.According to the complaint, the sterile saline allegedly continued to be sold and plaintiff continued using it.On (b)(6) 2024, plaintiff allegedly noticed redness and pain at her wire insertion site and developed an infection purportedly caused by the contaminated sterile saline.The infection allegedly remains in her blood today.".

• Brand Name: STERICARE SOLUTIONS
• Common Device Name: USP NORMAL SALINE
• Manufacturer (Section D): NURSE ASSIST, LLC; 4409, haltom road; haltom city TX 76117
• Manufacturer (Section G): NURSE ASSIST, LLC; 4409, haltom road; haltom city TX 76117
• Manufacturer Contact: amina agbonoga ; 4409, haltom road; haltom city, TX 76117 ; 8006496800
• MDR Report Key: 25074637
• Report Number: 3002695476-2026-00001
• Device Sequence Number: 16124604
• Product Code: FRO
• UDI-Device Identifier: 00850421008815
• UDI-Public: 850421008815
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

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 Model Number: 6240
• Device Catalogue Number: 6240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1650927-3OCT2023-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female