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	Bacterial Infection (1735)
Date of Event	09/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is in response to the letter received on (b)(6) 2024 by nurse assist from amazon's law firm due to the litigations of (b)(4).Nurse assist did not receive any complaint notice directly from (b)(6) about the complications he had with nurse assist product.On (b)(6) 2024, nurse assist opened this event as a complaint and will conduct an investigation with information that was provided in the letter.
Event or Problem Description
On (b)(6) 2024, nurse assist received a letter from (b)(4) via e-mail.Description of e-mail:claimant alleges he suffered severe injury, including toe amputations, due to his use of nonsterile saline solution purchased from a third-party seller, (b)(4), through amazon.Com.Specifically, claimant claims that he purchased 0.9% sodium chloride sterile saline 250ml manufactured by nurse assist.He alleges he used the product starting in (b)(6) 2023, until (b)(6) 2023, when he noticed toe discoloration on his left foot.He was later diagnosed with gangrene and underwent amputation of his left 2nd and 3rd toes.Claimant alleges the saline solution was part of a recall campaign as a result of being nonsterile.
Additional Manufacturer Narrative
This mdr is in response to the letter received on 02-feb-2024 by nurse assist from amazon's law firm due to the litigations of (b)(6).Nurse assist did not receive any complaint notice directly from (b)(6) about the complications he had with nurse assist product.On (b)(6) 2024, nurse assist opened this event as a complaint and will conduct an investigation with information that was provided in the letter.On (b)(6) 2024 nurse assist reopened the investigation for this event after being provided with the part and lot number of the product used.
Event or Problem Description
On (b)(6) 2024, nurse assist received a letter from (b)(6) via e-mail.Description of e-mail: claimant alleges he suffered severe injury, including toe amputations, due to his use of nonsterile saline solution purchased from a third-party seller, (b)(4), through amazon.Com.Specifically, claimant claims that he purchased 0.9% sodium chloride sterile saline 250ml manufactured by nurse assist.He alleges he used the product starting in (b)(6) 2023, until (b)(6) 2023, when he noticed toe discoloration on his left foot.He was later diagnosed with gangrene and underwent amputation of his left 2nd and 3rd toes.Claimant alleges the saline solution was part of a recall campaign as a result of being nonsterile.On 22-jul-2024 additional information was provided via email including a photo of the product used.The photo showed item part number 6270, lot # 23055547.

• 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: 19152619
• Report Number: 3002695476-2024-00019
• Device Sequence Number: 8450828
• Product Code: FRO
• UDI-Device Identifier: 00850421008822
• UDI-Public: 850421008822
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 04/12/2024

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: 05/10/2025
• Device Model Number: 6270
• Device Lot Number: 23055547
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Life Threatening; Hospitalization; Disability
• Patient Sex: Unknown