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

Model Number	6240
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Codes	Bacterial Infection (1735); Skin Infection (4544)
Date of Event	07/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 27-nov-23, nurse assist received a complaint via phone from robert hensl of the following event description from phone call with robert hensl: had an open wound on his back since (b)(6)2022, started receving home health care since (b)(6) 2023.Nurse order medical supplies that came with a 6240 saline bottle that was used to clean the open wound.The supplies are directly shipped to ronald's home.Wound did not get better after using nurse assist product.Ronald received the recall letter and called to report an adverse reaction.Adverse reaction was that the nurse assist product did not help with treating his open wound on his back.In november, the doctor cultured the wound and results came back with 2 infections.Doctor prescribed ronald with 2 antibiotics, ciprofloxacin and linezolid, to treat the infection.Doctor checkup on (b)(6) 2023, wound is getting better with the use of the 2 antibiotics.23024895 (2 bottle), 23035031 (2 bottles), 23045346 (2 bottles), 23024921 (1 bottles).

• Brand Name: NURSE ASSIST, LLC
• Common Device Name: 0.9% NORMAL SALINE FOR IRRIGATION USP, IN SCREW TOP BOTTLE
• 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: 18402473
• Report Number: 3002695476-2023-00033
• Device Sequence Number: 14114915
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2023

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: 04/20/2025
• Device Model Number: 6240
• Device Lot Number: 23045346
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2023
• 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