MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SOLUTION SET TUBING; SET, I.V. FLUID TRANSFER

Model Number C8296

Patient Problem Insufficient Information (4580)

Event Date 01/21/2024

Event Type  Injury  

Event Description

For emergent embolization procedure, noticed that tubing used for procedure has now started to develop bubbles.(this is a contraindication to for using this product.) looking into process, found out manufacture changed process.Comes as a custom kit from medline.Unable to acquire specific lot or catalog number.Came in with aneurysm that needed treatment.

• Brand Name: SOLUTION SET TUBING
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 18588641
• MDR Text Key: 333961516
• Report Number: MW5150754
• Device Sequence Number: 1
• Product Code: LHI
• 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: 01/22/2024

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 Operator: Health Professional
• Device Model Number: C8296
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female