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

Model Number	37-6270
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Codes	Septic Shock (2068); Fungal Infection (2419)
Date of Event	11/20/2023
Type of Reportable Event	Death
Event or Problem Description
On 28-nov-23, nurse assist received a medwatch report (mw5148357) via e-mail of the following event description from medwatch report: cder received the medwatch report.The reporter states the impacted individual had an ulcer wound that got infected with candida auris.They washed the wound daily with water.There were white spores (fungal growth) around the wounds.The hospital determined that candida auris got into the blood stream of the impacted individual and the individual went into septic shock and died.The reporter stated that they have the medical records for the deceased individual.Infection leading to death.
Additional Manufacturer Narrative
We received a medwatch from the fda, but neither the anonymous reporter nor the fda would or could provide any information that would allow us to conduct a meaningful investigation.We are therefore filing an mdr based on the medwatch but cannot make any determination as to whether the reported event actually happened, and if it did whether it involved our products, and if it did whether those products actually contributed to the reported event.

• 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 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: 18387517
• Report Number: 3002695476-2023-00014
• Device Sequence Number: 17918152
• Product Code: FRO
• UDI-Device Identifier: 00612479199576
• UDI-Public: 612479199576
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 12/21/2023

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: 08/11/2024
• Device Model Number: 37-6270
• Device Catalogue Number: N/A
• Device Lot Number: 22083817
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2022
• 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: Death
• Patient Sex: Unknown