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

Model Number	6240
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 4-jul-2023, customer notified nurse assist via e-mail of the following event description from a customer: (translated) is rust inside the tray, it appears to be nacl leaking from the bottle as it is almost empty.This is the third kit that contains rust and is not usable.I'll let you know if there are any others.Photos of the kit in question are attached.These bottles were reported by the initial reporter as leaking prior to use on a patient.There was no report of any patient impact or adverse event.
Additional Manufacturer Narrative
The extended time between date of event and date of this report is due to nurse assist recently reclassifying this type of occurrence as having the potential for causing or contributing to a death or a serious injury if the malfunction were to recur.Nurse assist is conducting a retrospective review of product complaints to identify all occurrences of malfunction of the sterile barrier.

• Brand Name: NURSE ASSIST, LLC
• Common Device Name: 0.9% NORMAL SLAINE FOR IRRIGATION USP, IN SCREW TOP BOTTLE
• Manufacturer (Section D): NURSE ASSIST, LLC; 4409 haltom rd.; haltom city 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: 18255616
• Report Number: 3002695476-2023-00012
• Device Sequence Number: 20504491
• Product Code: FRO
• UDI-Device Identifier: 10850421008812
• UDI-Public: (01)10850421008812
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/13/2024
• Device Model Number: 6240
• Device Catalogue Number: N/A
• Device Lot Number: 22073614
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2023
• Initial Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2022
• 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: Initial
• 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
• Patient Sex: Unknown