MAUDE Adverse Event Report: NURSE ASSIST, LLC. 10ML 0.9% SODIUM CHLORIDE FLUSH; SALINE, VASCULAR ACCESS FLUSH

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)

Event Date 12/02/2022

Event Type  Death  

Event Description

My husband was diagnosed with laryngeal cancer on (b)(6) 2022 and had a trach placed immediately in the er(emergency room) at (b)(6).He was treated from (b)(6) 2022 through (b)(6) 2022.He was hospitalized 4 different times at mayo from (b)(6) 2022 through (b)(6) 2023 for repeated infections.During this time, i was having to clean (b)(6)'s trach by completely removing it and flushing it with saline water before reentering it into his stoma, rinsing the inner cannula, and cleaning around his feeding tube with 0.9% saline solution and saline water given to me from mayo in (b)(6).Also, i had to administer saline flushes for iv infusions 3x a day for 9 days each of those times at home 2 separate times after hospitalization due to bacterial infections.First administered saline syringe flushes 10ml before and after in his midline before administering cefazolin.The second time was 10ml before and after in his midline before administering cefepime.(b)(6) passed away on (b)(6) 2023, 3 days after his last hospitalization.It is my concern that (b)(6) repeated bacterial infections may have been linked to the excessive use of 0.9% contaminated saline solution and saline water during this time.

• Brand Name: 10ML 0.9% SODIUM CHLORIDE FLUSH
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): NURSE ASSIST, LLC.
• MDR Report Key: 18300610
• MDR Text Key: 330163452
• Report Number: MW5149038
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: PROBIOTIC
• Patient Outcome(s): Other; Hospitalization; Death; Disability
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White