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

Model Number	6240
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Codes	Bacterial Infection (1735); Skin Inflammation/ Irritation (4545)
Date of Event	11/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported four different lot numbers 21081984, 21112421, 22104138, 22094074.
Event or Problem Description
On 25-march-2024, nurse assist received a medwatch report from the fda via e-mail.Description of email: reporter calling, stating she received a "deep" serratia bacterial infection of her heartmate 3 lvad (left ventricular assist device) driveline after using recalled saline.Reporter states on approximately (b)(6) 2023, she initially noticed her skin was turning red around her driveline.Reporter states that around this same time, she received a letter notification that the "nurse assist" saline supplied to her was under recall.Reporter states she stopped using this saline and was provided a different product, however the redness around her driveline site persisted, eventually turning "bright, tomato red" which resulted in an emergency room visit on (b)(6) 2024.Reporter states she was hospitalized for a serratia bacterial infection, and had to undergo a "seven-hour surgery" to remove infected tissue from around her lvad driveline, and the infection extended deep into her body.Reporter states she was discharged from the hospital on (b)(6) 2024, and is currently prescribed antibiotics.Reporter states she wants to report about her problems so that others may possibly avoid the troubles she has experienced due to use of this recalled saline product.On 26-march-2024, nurse assist reached out to customer via phone call and email.Description of email: email contained images of multiple saline products including bottles and syringes.Nurse assist products pictured included part number 6240( lots 21081984 & 21112421) and part number 1020 (lots 22104138 & 22094074).

• 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: 19069968
• Report Number: 3002695476-2024-00013
• Device Sequence Number: 6853754
• Product Code: FRO
• UDI-Device Identifier: 00850421008815
• UDI-Public: 850421008815
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/01/2024

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: 09/01/2023
• Device Model Number: 6240
• Device Lot Number: 21081984, 21112421
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2021
• 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; Hospitalization; Life Threatening
• Patient Sex: Unknown