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

Model Number	37-6270, 6270
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
On 16-apr-2024 nurse assist received a complaint via phone for the following event.Description from nurse assist customer service: a person called in and said that she/he used saline, and it caused her/him to get multiple infections.She/him used it to used it irrigate her/his pouch (bladder made out of intestines).She said she took enough to fill the syringe to irrigate it once and threw away the rest.So, she did inject it into her body.The infection caused it to come out like cottage cheese when she/he irrigated it (that is what came out).She/he had three bottles left but they only gave me lot# on 2.The 3rd was just an expiration date.Lot# 23045430, 22124487, 1/5/25.Name: (b)(6) # (b)(6).She/he wants to know what bacteria is in the product so she can tell doctor so they can figure out how to treat it.Nothing they are doing is helping get over the infection.The person has the pouch for 14 years.

• 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: rebeca masdon-mercado ; 4409 haltom rd.; haltom city, TX 76117 ; 8006496800
• MDR Report Key: 19201682
• Report Number: 3002695476-2024-00023
• Device Sequence Number: 8021788
• Product Code: FRO
• UDI-Device Identifier: 00850421008822
• UDI-Public: 850421008822
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/24/2024

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
• Device Expiration Date: 12/09/2024
• Device Model Number: 37-6270, 6270
• Device Lot Number: 23045430, 22124487
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2022
• 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: Required Intervention
• Patient Sex: Unknown