MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. ONE-LINK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 7N8399

Device Problems Complete Blockage (1094); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 07/01/2021

Event Type  malfunction  

Event Description

Brown lumen flushed on central line and cap caught blood clot ,which got stuck in the needleless one-link needle-free iv connector.Same issue occurred when blue lumen flushed.

• Brand Name: ONE-LINK
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 12252059
• MDR Text Key: 264310930
• Report Number: 12252059
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7N8399
• Device Catalogue Number: 7N8399
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2021
• Date Report to Manufacturer: 07/30/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA