MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. CLEARLINK; SET, BLOOD TRANSFUSION

Model Number 2C8750

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Insufficient Information (4580)

Event Date 08/02/2021

Event Type  malfunction  

Event Description

A nurse brought to the attention that she observed that there was a small piece of plastic/foreign body in the y site tubing of blood tubing: clearlink system 2c8750.The packaging is marked as follows: (01) 00085412046341, lot (10) dr21c19031.

• Brand Name: CLEARLINK
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 12413251
• MDR Text Key: 269581575
• Report Number: 12413251
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2C8750
• Device Catalogue Number: 2C8750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/27/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1