MAUDE Adverse Event Report: NURSE ASSIST, LLC. 0.9% SODIUM CHLORIDE IRRIGATION USP (STERICARE SOLUTIONS); SALINE, VASCULAR ACCESS FLUSH

Lot Number 21071702

Patient Problems Purulent Discharge (1812); Drug Resistant Bacterial Infection (4553)

Event Date 04/11/2023

Event Type  Injury  

Event Description

Ordered and used on patient beginning in (b)(6) 2022 due to nationwide shortage of saline solution to clean port (biliary) drainage from wound site.Developed life-threatening mrsa at that site shortly in (b)(6) 2022.According to records: wound culture collected on (b)(6) 2022 with result for positive mrsa on (b)(6) 2022.Hospitalized at (b)(6) hospital on strong antibiotic (vancomycin) treatment thereafter.

• Brand Name: 0.9% SODIUM CHLORIDE IRRIGATION USP (STERICARE SOLUTIONS)
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): NURSE ASSIST, LLC.
• MDR Report Key: 18300912
• MDR Text Key: 330166776
• Report Number: MW5149043
• 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: Unknown
• Type of Report: Initial
• Report Date: 11/07/2023

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
• Device Expiration Date: 08/04/2023
• Device Lot Number: 21071702
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2023
• Patient Sequence Number: 1
• Treatment: CPAP - AS NEEDED; CREON; PROTONIX
• Patient Outcome(s): Other; Life Threatening; Required Intervention; Hospitalization; Disability
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 42 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian