MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. CLEARLINK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2R8547

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 02/11/2023

Event Type  malfunction  

Event Description

Tpn tubing leaking from y-sites, changed per protocol.This poses a risk for central line infections in a population where this is already on the rise.Manufacturer response for iv tubing, clearlink (per site reporter) they have made manufacturing corrective actions and will be sending us tubing for our sites to use from the new production.

• Brand Name: CLEARLINK
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 16442786
• MDR Text Key: 310247590
• Report Number: 16442786
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2R8547
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/27/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1