MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 0.9% SODIUM CHLORIDE IRRIGATION USP, 3000 ML ARTHROMATIC PLASTIC CONTAINER; SYSTEM, IRRIGATION, UROLOGICAL

Model Number	2B7477
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
3000ml normal saline (ns) spiked for a transurethral resection of the prostate (turp).The spike was sufficiently inserted but no saline would proceed through the tubing.It was noted that the tubing that enters into the bag of ns was completely fused together causing no ns to pass through.Multiple attempts were made to open the fused end but could not.The bag was changed to a new one.Saline bag info: baxter 3000ml 0.9% ns bag ref # 2b7477 lot y426800 expiring july 2025.

• Brand Name: 0.9% SODIUM CHLORIDE IRRIGATION USP, 3000 ML ARTHROMATIC PLASTIC CONTAINER
• Common Device Name: SYSTEM, IRRIGATION, UROLOGICAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 18777382
• Report Number: 18777382
• Device Sequence Number: 19210615
• Product Code: LJH
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2023
• Report Date (Section F): 11/14/2023

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
• Device Model Number: 2B7477
• Device Catalogue Number: 2B7477
• Device Lot Number: Y426800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2024
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/14/2023